Drug Information

View drug alerts Information in California, Georgia, or New York
 
The Drug Information Center has a wealth of information to help you understand how drugs impact your health as well as their place in today's healthcare environment. 
 
The information you'll find in the center covers a number of important topics ranging from drug safety and side effects to medication costs and errors. You'll also notice from time to time we will display drug alerts. These alerts will let you know when a New Drug is put on the market, if a drug has been recalled, and if a drug has a new indication or use. 
 
 
Drug Name Drug Reason Date
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab injection) for the treatment of individuals with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate targeted therapy if their tumor has epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) gene abnormalities. Source: FDA website
New Indication 10-18-16
Equetro
The Food and Drug Administration (FDA) approved Equetro® (carbamazepine extended-release capsules) for the treatment of individuals with partial seizures with complex symptomatology, generalized tonic-clonic seizures, and mixed seizures, and the treatment of individuals with pain associated with trigeminal neuralgia. Source: FDA website
New Indication 9-23-16
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the first-line treatment of individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score [TPS] of 50 percent or more) as determined by a Food and Drug Administration (FDA)-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. Source: FDA website
New Indication 10-24-16
Zemplar
The Food and Drug Administration (FDA) approved Zemplar® (paricalcitol capsules) to include the prevention and treatment of secondary hyperparathyroidism in individuals 10 years and older with chronic kidney disease (CKD) stage 3 or 4 and in individuals 10 years and older with CKD stage 5 who are on hemodialysis or peritoneal dialysis. Source: FDA website
New Indication 10-20-16
Carnexiv
The Food and Drug Administration (FDA) approved CarnexivTM (carbamazepine injection) as short-term replacement therapy for oral carbamazepine when oral administration is temporarily not feasible. Source: FDA website
New Drug 10-07-16
Flublok Quadrivalent
The Food and Drug Administration (FDA) approved Flublok®® Quadrivalent (influenza vaccine injection) for active immunization against disease caused by influenza A virus subtypes and influenza B virus in adults. It contains the three strains found in trivalent Flublok plus an additional B strain. Source: FDA website
New Drug 10-11-16
Lartruvo
The Food and Drug Administration (FDA) approved LartruvoTM (olaratumab injection) for combination therapy with doxorubicin for soft tissue sarcoma in adults with a histologic subtype that is expected to respond to doxorubicin and cannot be cured with surgery or radiation. Source: FDA website
New Drug 10-19-16
Zinplava
The Food and Drug Administration (FDA) approved ZinplavaTM (bezlotoxumab injection) to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial treatment of CDI and are at high risk for CDI recurrence. Source: FDA website
New Drug 10-24-16
Testosterone and other anabolic androgenic steroids
The Food and Drug Administration (FDA) approved class labeling for all prescription testosterone products, adding a new Warning and updating the Abuse and Dependence section to include new safety information from published literature and case reports regarding the risks associated with abuse and dependence of these products. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526151.htm Source: FDA website
Drug Warning 10-25-16
Kerydin
The Food and Drug Administration (FDA) approved KerydinTM (tavaborole topical solution) for the treatment of toenail fungus. Source: FDA website
New Drug 07-07-14
Zydelig
The Food and Drug Administration (FDA) approved Zydelig® (idelalisib tablets) in combination with rituximab for individuals with relapsed chronic lymphocytic leukemia (CLL) for whom rituxumab alone would be considered appropriate therapy, as monotherapy for individuals with relapsed follicular B-cell non-Hodgkin lymphoma (FL) who have received at least two prior therapies and small lymphocytic lymphoma (SLL) who have received at least two prior systemic therapies. Source: FDA website
New Drug 07-23-14
Ruconest
The Food and Drug Administration (FDA) approved Ruconest® (C1 esterase inhibitor injection) for the treatment of acute angioedema attacks in adults and adolescents with hereditary angioedema (HAE). Source: FDA website
New Drug 07-17-14
Acticlate
The Food and Drug Administration (FDA) approved ActiclateTM (doxycycline hyclate tablets) for the treatment of susceptible infections including adjunctive therapy in severe acne. Source: FDA website
New Drug 07-25-14
Rasuvo
The Food and Drug Administration (FDA) approved RasuvoTM (methotrexate subcutaneous auto-injection) for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis. Source: FDA website
New Drug 07-14-14
Octagam 10%
The Food and Drug Administration (FDA) approved Octagam® 10% (immune globulin intravenous injection) for the treatment of adults with chronic immune thrombocytopenic purpura (ITP). Source: FDA website
New Indication 07-15-14
Ryanodex
The Food and Drug Administration (FDA) approved Ryanodex® (dantrolene sodium injection) for the treatment of malignant hyperthermia (MH), along with appropriate supportive measures. Source: FDA website
New Drug 07-23-14
Targiniq ER
The Food and Drug Administration (FDA) approved TarginiqTM ER (oxycodone/naloxone tablets) for the treatment of severe pain. Source: FDA website
New Drug 07-24-14
NovoSeven RT
The Food and Drug Administration (FDA) approved NovoSeven® RT (coagulation factor VIIa, recombinant injection) for the treatment of bleeding episodes and perioperative management in individuals with Glanzmann's Thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets. Source: FDA website
New Indication 07-07-14
Imbruvica
The Food and Drug Administration (FDA) approved ImbruvicaTM (ibrutinib capsules) for the treatment of individuals with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion). Source: FDA website
New Indication 07-28-14
Mekinist and Tafinlar
The Food and Drug Administration approved Mekinist® (trametinib tablets) and Tafinlar® (dabrafenib capsules) for combination use in unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. Source: FDA website
New Indications 01-09-14
Isentress
The Food and Drug Administration (FDA) approved Isentress® (raltegravir oral suspension) for the treatment of human immunodeficiency virus (HIV)-1 infection in pediatric patients. Source: FDA website
New Drug 01-08-14
Farxiga
The Food and Drug Administration (FDA) approved FarxigaTM (dapagliflozin tablets) to improve glycemic control, with diet and exercise, in adults with type 2 diabetes. Source: FDA website
New Drug 01-08-14
TRUEtrack and TRUEbalance blood glucose meters
Nipro Diagnostics announced a voluntary recall of a limited number of TRUEbalance® and TRUEtrack® blood glucose meters due an incorrect factory-set unit of measure. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380758.htm Source: FDA website
Drug Warnings 01-08-14
Sodium Phosphate over-the-counter products
The Food and Drug Administration (FDA) is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and possible death. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm380833.htm Source: FDA website
Drug Warnings 01-08-14
Pennsaid
The Food and Drug Administration (FDA) approved Pennsaid® (diclofenac sodium 2% topical solution) for the treatment of osteoarthritis pain of the knee. Source: FDA website
New Drug 01-17-14
Copaxone
The Food and Drug Administration (FDA) approved Copaxone® (glatiramer acetate 40 mg injection) for the treatment of multiple sclerosis. This new formulation can be administered three times a week. Source: FDA website
New Drug 01-28-14
Hetlioz
The Food and Drug Administration (FDA) approved HetliozTM (tasimelteon capsules) for the treatment of non-24-hour sleep-wake disorder (non-24) in blind individuals. Source: FDA website
New Drug 01-31-14
t:slim Insulin Cartridges
Tandem Diabetes Care announced a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump due to a risk for leaking. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381606.htm Source: FDA website
Drug Recall 01-14-14
Acetaminophen Prescription Combination Drug Products
The Food and Drug Administration (FDA) recommended that health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 mg of acetaminophen per dosage unit due to the potential for liver injury. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm381650.htm Source: FDA website
Drug Warning 01-14-14
Calcium gluconate
The Food and Drug Administration (FDA) notified healthcare professionals to follow up with individuals who received calcium gluconate 10% injections made by Rx Formulations in Mesa, AZ between November 7, 2013 and December 11, 2013. FDA testing confirmed the presence of microbial contamination in one lot of calcium gluconate product. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385125.htm Source: FDA website
Drug Warning 02-07-14
Imbruvica
The Food and Drug Administration (FDA) approved ImbruvicaTM (ibrutinib capsules) as a single agent for individuals with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Source: FDA website
New Indications 02-12-14
Kalydeco
The Food and Drug Administration (FDA) approved KalydecoTM (ivacaftor tablets) for use in individuals with cystic fibrosis (CF) ages 6 years older who have 1 of 8 additional mutations in the CF transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indications 02-21-14
Vimizim
The Food and Drug Administration (FDA) approved VimizimTM (elosulfase alfa injection) for the treatment of Mucopolysaccharidosis Type IVA (Morquio A syndrome). Source: FDA website
New Drug 02-14-14
Northera
The Food and Drug Administration (FDA) approved NortheraTM (droxidopa capsules) for the treatment of symptomatic neurogenic orthostatic hypotension. Source: FDA website
New Drug 02-18-14
Tivorbex
The Food and Drug Administration (FDA) approved TivorbexTM (indomethacin capsules) for the treatment of mild-to-moderate acute pain in adults. Source: FDA website
New Drug 02-24-14
Myalept
The Food and Drug Administration (FDA) approved MyaleptTM (metreleptin injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in individuals with congenital generalized or acquired generalized lipodystrophy. Source: FDA website
New Drug 02-24-14
Bydureon Pen
The Food and Drug Administration (FDA) approved Bydureon® Pen (exenatide extended-release for injectable suspension) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website
New Drug 03-03-14
Aveed
The Food and Drug Administration (FDA) approved AveedTM (testosterone undecanoate injection) as a testosterone replacement therapy for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism and hypogonadotropic hypogonadism in adult males. Source: FDA website
New Drug 03-06-14
Xartemis XR
The Food and Drug Administration (FDA) approved XartemisTM XR (oxycodone/acetaminophen extended-release tablets) for the management of acute pain severe enough to require opioid treatment and in individuals for whom alternative options are ineffective, not tolerated or would otherwise be inadequate. Source: FDA website
New Drug 03-12-14
Qudexy XR
The Food and Drug Administration (FDA) approved QudexyTM XR (topiramate extended-release capsules) as initial monotherapy in individuals greater than 10 years of age with partial-onset seizures or primary generalized tonic-clonic seizures. Qudexy XR is also approved as adjunct therapy in individuals greater than 2 years of age with partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome. Source: FDA website
New Drug 03-12-14
Effexor XR 150 mg and Venlafaxine XR 150 mg
Pfizer announced a recall on one lot of 30-count Effexor XR® 150 mg extended-release capsules, one lot of 90-count Effexor XR 150 mg extended-release capsules, and one lot of 90-count Greenstone branded Venlafaxine 150 mg extended-release capsules. The recall is due to a report that one bottle of Effexor XR contained one capsule of Tikosyn® (dofetilide). Contact your healthcare professional with any questions. Details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388352.htm Source: FDA website
Drug Recall 03-07-14
Eliquis
The Food and Drug Administration (FDA) approved Eliquis® (apixaban tablets) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in individuals who have undergone hip or knee replacement surgery. Source: FDA website
New Indications 03-14-14
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection) for the treatment of chronic idiopathic urticaria (CIU) in individuals greater than 12 years of age who remain asymptomatic despite H1-antihistamine therapy. Source: FDA website
New Indications 03-21-14
Impavido
The Food and Drug Administration (FDA) approved Impavido® (miltefosine capsules) in adults and adolescents for the treatment of visceral leishmaniasis, cutaneous leishmaniasis, and, mucosal leishmaniasis. Source: FDA website
New Drug 03-19-14
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of psoriatic arthritis. Source: FDA website
New Drug 03-21-14
Noxafil
The Food and Drug Administration (FDA) approved Noxafil® (posaconazole injection) for prophylaxis against invasive Aspergillus and Candida infections, in individuals at high risk due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft vs. host disease (GVHD), or those with hematologic malignancies with prolonged neutropenia due to chemotherapy. Source: FDA website
New Drug03-14-14
Hemangeol
The Food and Drug Administration (FDA) approved HemangeolTM (propranolol oral solution) for the treatment of proliferating infantile hemangioma requiring systemic therapy. Source: FDA website
New Drug 03-17-14
Metronidazole Vaginal Gel 1.3%
The Food and Drug Administration (FDA) approved Metronidazole Vaginal Gel 1.3% for the treatment of bacterial vaginosis. Source: FDA website
New Drug03-26-14
Adacel
The Food and Drug Administration (FDA) approved Adacel® (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine; adsorbed injection) to immunize against tetanus, diphtheria, and pertussis in children as young as 10 years old. Source: FDA website
New Indications04-01-14
Alli
GlaxoSmithKline and Consumer Healthcare announced a recall of all AlliTM (orlistat capsules) weight loss products due to the possibility of product tampering. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm391013.htm Source: FDA website
Drug Recall03-28-14
Alprolix
The Food and Drug Administration (FDA) approved AlprolixTM (coagulation Factor IX recombinant, Fc fusion protein injection) to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and to prevent or reduce the frequency of bleeding episodes in individuals with hemophilia B. Source: FDA website
New Drug03-28-14
Evzio
The Food and Drug Administration (FDA) approved EvzioTM (naloxone injection) for the emergency treatment of opioid overdose. Source: FDA website
New Drug04-03-14
Kalbitor
The Food and Drug Administration (FDA) approved Kalbitor® (ecallantide injection) for the treatment of acute attacks of hereditary angioedema (HAE) in individuals greater than 12 years old. Source: FDA website
New Indications04-03-14
Oralair
The Food and Drug Administration (FDA) approved Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract sublingual tablet) for the treatment of allergic rhinitis with or without conjunctivitis caused by certain grass pollens in individuals aged 10 to 65 years. Source: FDA website
New Drug04-02-14
Pradaxa
The Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate mesylate capsules) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in individuals who have been treated with a parenteral anticoagulant for 5-10 days, and to reduce the risk of recurrent DVT and PE in previously treated patients. Source: FDA website
New Indications04-07-14
Topamax
The Food and Drug Administration (FDA) approved Topamax® (topiramate tablets) for prevention of migraines in adolescents aged 12-17 years old. Source: FDA website
New Indications03-28-14
Grastek
The Food and Drug Administration (FDA) approved Grastek® (Timothy grass pollen allergen extract sublingual tablet) for the treatment of grass-pollen induced allergic rhinitis with or without conjunctivitis in individuals aged 5 to 65 years. Source: FDA website
New Drug04-15-14
Ragwitek
The Food and Drug Administration (FDA) approved RagwitekTM (short ragweed pollen allergen extract sublingual tablet) for the treatment of short ragweed pollen induced allergic rhinitis with or without conjunctivitis in individuals aged 18 to 65 years. Source: FDA website
New Drug04-17-14
Tanzeum
The Food and Drug Administration (FDA) approved TanzeumTM (albiglutide subcutaneous injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website
New Drug04-15-14
Cyramza
The Food and Drug Administration (FDA) approved CyramzaTM(ramucirumab injection) for the treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma, as a single-agent after prior fluoropyrimidine- or platinum-containing chemotherapy. Source: FDA website
New Drug04-21-14
Sylvant
The Food and Drug Administration (FDA) approved SylvantTM (siltuximab injection) for the treatment of multicentric Castleman's disease (MCD). Source: FDA website
New Drug04-23-14
Arzerra
The Food and Drug Administration (FDA) approved Arzerra® (ofatumumab injection) for use in combination with chlorambucil for the treatment of previously untreated individuals with chronic lymphocytic leukemia (CLL) for whom, fludarabine-based therapy is considered inappropriate. Source: FDA website
New Indications04-17-14
Cubicin
Cubist Pharmaceuticals announced a recall of one lot of Cubicin® (daptomycin 500 mg injection) due to the presence of particulate matter. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394025.htm Source: FDA website
Drug Warning04-18-14
Lidocaine
Hospira announced a recall of one lot of Lidocaine 1%, 10 mg/mL, 30 mL single dose, preservative-free vials due to the presence of visible particulates. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm394026.htm Source: FDA website
Drug Warning04-19-14
Purixan
The Food and Drug Administration (FDA) approved PurixanTM (mercaptopurine oral suspension) for the treatment of individuals with acute lymphoblastic leukemia (ALL) as part of a combination regimen. Source: FDA website
New Drug04-29-14
Zykadia
The Food and Drug Administration (FDA) approved ZykadiaTM (ceritinib capsules) for individuals with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Source: FDA website
New Drug04-29-14
Incruse Ellipta
The Food and Drug Administration (FDA) approved IncruseTM Ellipta® (umeclidinium oral inhaler) for the long-term, once-daily, maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Drug04-30-14
Epanova
The Food and Drug Administration (FDA) approved EpanovaTM(omega-3-carboxylic acids capsules) as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (>500 mg/dL). Source: FDA website
New Drug05-06-14
Zontivity
The Food and Drug Administration (FDA) approved ZontivityTM (vorapaxar tablets) to reduce the risk of heart attack, stroke, cardiovascular death, and need for coronary revascularization in individuals with a previous heart attack or blockages in the arteries to the legs. Source: FDA website
New Drug05-08-14
Kogenate FS
The Food and Drug Administration (FDA) approved Kogenate FS® (antihemophilic factor VIII, recombinant injection) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A. Source: FDA website
New Indications05-12-14
GenStrip Blood Glucose Test Strips
The Food and Drug Administration (FDA) has advised consumers and health care professionals to stop using GenStrip Blood Glucose Test Strips by Shasta Technologies because the strips may report incorrect blood glucose levels. The FDA recommends the use of alternative glucose test strips designed for use with the LifeScan OneTouch family of glucose meters. Contact your health care professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm395270.htm Source: FDA website
Drug Warning04-29-14
Entyvio
The Food and Drug Administration (FDA) approved Entyvio® (vedolizumab injection) for the treatment of adults with moderate to severe ulcerative colitis and Crohn's disease. Source: FDA website
New Drug05-19-14
Dalvance
The Food and Drug Administration (FDA) approved Dalvance™ (dalbavancin injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus). Source: FDA website
New Drug05-23-14
Natesto
The Food and Drug Administration (FDA) approved Natesto™ (testosterone nasal gel) for replacement therapy in adult males with conditions associated with a deficiency or absence of endogenous testosterone, including primary hypogonadism and hypogonadotropic hypogonadism. Source: FDA website
New Drug05-29-14
Vectibix
The Food and Drug Administration (FDA) approved Vectibix® (panitumumab injection) for use in combination with FOLFOX chemotherapy as a first-line treatment in individuals with wild-type KRAS (exon 2) metastatic colorectal cancer. A companion diagnostic test was also approved. Source: FDA website
New Indications05-27-14
Aloxi
The Food and Drug Administration (FDA) approved Aloxi® (palonosetron injection) for the prevention of acute nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in children aged 1 month to < 17 years. Source: FDA website
New Indications05-28-14
Lunesta
The Food and Drug Administration (FDA) announced a warning that the insomnia drug Lunesta® (eszopiclone tablets) and its generics may cause next-day impairment of driving and other activities that require alertness. The agency recommends a decreased starting dose of Lunesta to 1 mg at bedtime. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397536.htm Source: FDA website
Drug Warning05-15-14
Pradaxa
The Food and Drug Administration (FDA) completed a study comparing Pradaxa® (dabigatran capsules) to warfarin and found that Pradaxa was associated with a lower risk for stroke and death but a higher risk for gastrointestinal bleeding compared with warfarin. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397179.htm Source: FDA website
Drug Warning05-13-14
Labetalol
Hospira announced a recall of one lot of Labetalol Hydrochloride Injection 100 mg/20 mL multidose vial due to the presence of visible particulates. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm397775.htm Source: FDA website
Drug Recall05-16-14
Vogelxo
The Food and Drug Administration (FDA) approved Vogelxo™ (testosterone topical gel) for testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone including primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired). Source: FDA website
New Drug06-04-14
Jublia
The Food and Drug Administration (FDA) approved Jublia® (efinaconazole topical solution) for the treatment of onychomycosis of the toenails. Source: FDA website
New Drug06-09-14
Eloctate
The Food and Drug Administration (FDA) approved Eloctate™ (coagulation factor VIII recombinant, Fc fusion protein injection) for use in adults and children with hemophilia A. Source: FDA website
New Drug06-09-14
Bunavail
The Food and Drug Administration (FDA) approved Bunavail™ (buprenorphine/naloxone buccal film) for the maintenance treatment of opioid dependence. Source: FDA website
New Drug06-09-14
Nascobal
The Food and Drug Administration (FDA) approved Nascobal® (cyanocobalamin nasal spray) single-use disposable device for the maintenance of normal hematologic status in pernicious anemia and for other vitamin B12 deficiencies. Source: FDA website
New Drug06-10-14
Azilect
The Food and Drug Administration (FDA) approved Azilect® (rasagiline tablets) for the expanded indication of adjunct treatment to dopamine agonists in Parkinson's disease. Source: FDA website
New Indication06-09-14
Advocate Redi-Code+
Diabetic Supply of Suncoast announced a voluntary recall of all Advocate Redi-Code+ blood glucose test strips manufactured by BroadMaster Bio-Tech Corp due to a labeling error which could result in confusion about which meter models the test strips are designed to be used with. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm400668.htm Source: FDA website
Drug Recall06-11-14
Sivextro
The Food and Drug Administration (FDA) approved SivextroTM (tedizolid tablet and injection) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI), including methicillin-resistant Staphylococcus aureus (MRSA). Source: FDA website
New Drug06-23-14
Afrezza
The Food and Drug Administration (FDA) approved Afrezza® (human insulin injection) for the improvement of glycemic control in adults with diabetes mellitus. Source: FDA website
New Drug06-30-14
Beleodaq
The Food and Drug Administration (FDA) approved BeleodaqTM (belinostat injection) for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL). Source: FDA website
New Drug07-03-14
Ozurdex
The Food and Drug Administration (FDA) approved Ozurdex® (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME) in adults who have an artificial lens implant or who are scheduled for cataract surgery. Source: FDA website
New Indications07-01-14
Lidocaine Viscous
The Food and Drug Administration (FDA) announced that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. The agency is requiring a Boxed Warning to be added to labeling. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402790.htm Source: FDA website
Drug Warning06-26-14
Over-the-Counter Topical Acne Products
The Food and Drug Administration (FDA) announced that certain over-the-counter (OTC) topical acne products may cause rare but serious potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use. The OTC topical acne products of concern are marketed under various brand names such as Proactiv®, Neutrogena®, MaxClarity™, Oxy™, Ambi®, Aveeno®, Clean & Clear®, and as store brands. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm402722.htm Source: FDA website
Drug Warning06-25-14
Coumadin
Bristol-Myers Squibb announced a voluntary recall of six lots of Coumadin®, (warfarin injection) 5 mg single-use vials due to the presence of particulate matter. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm403583.htm Source: FDA website.
Drug Recall07-01-14
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) for the treatment of diabetic macular edema (DME). Source: FDA website.
New Indication 07-30-14
Lumizyme
The Food and Drug Administration (FDA) approved LumizymeTM(alglucosidase alfa injection) for the treatment of individuals with infantile-onset Pompe disease, including individuals who are < 8 years old. Source: FDA website.
New Indication 08-01-14
Striverdi Respimat
The Food and Drug Administration (FDA) approved Striverdi® Respimat® (olodaterol oral inhalation) for the treatment of individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema with airflow obstruction. Source: FDA website.
New Drug 07-31-14
Jardiance
The Food and Drug Administration (FDA) approved Jardiance® (empagliflozin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Source: FDA website.
New Drug 08-01-14
Orbactiv
The Food and Drug Administration (FDA) approved OrbactivTM(oritavancin injection) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible designated Gram-positive bacteria. Source: FDA website.
New Drug 08-07-14
Orkambi
The Food and Drug Administration (FDA) approved OrkambiTM (lumacaftor/ivacaftor tablets) for the treatment of cystic fibrosis (CF) in individuals age 12 and older who are homozygous for the F508del mutation in the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene. Source: FDA website
New Drug 07-02-15
Lidocaine Injection
Hospira announced a recall of one lot of Lidocaine injection 2%, 20 mg/mL, 5 mL preservative-free, single-dose vial due to a report of discolored product with visible particulates. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm407249.htm Source: FDA website.
Drug Recall 07-30-14
RegenESlim Appetite Control
Regeneca Worldwide announced a recall of RegenESlim Appetite Control dietary supplement due to the presence of DMAA. The Food and Drug Administration (FDA) has warned that 1,3-dimethylamylamine (DMAA) can cause potentially dangerous cardiovascular problems. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408681.htm Source: FDA website.
Drug Recall 08-07-14
Velcade
The Food and Drug Administration (FDA) approved Velcade® (bortezomib injection) for the retreatment of adults with multiple myeloma who had previously reponded to Velcade therapy and relapsed at least six months following completion. Source: FDA website
New Indication 08-10-14
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent, or metastatic cervical cancer. Source: FDA website
New Indication 08-15-14
Eliquis
The Food and Drug Administration (FDA) approved Eliquis® (apixaban tablets) for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy. Source: FDA website
New Indication 08-21-14
Invokamet
The Food and Drug Administration (FDA) approved InvokametTM (canagliflozin/metformin tablets) for the treatment of adults with type 2 diabetes. Source: FDA website
New Drug 08-11-14
Belsomra
The Food and Drug Administration (FDA) approved Belsomra® (suvorexant tablets) for the treatment of insomnia. Source: FDA website
New Drug 08-13-14
Nutrilipid
The Food and Drug Administration (FDA) approved Nutrilipid® (20% fat emulsion injection) for parenteral nutrition therapy in adults and pediatric individuals. Source: FDA website
New Drug 08-13-14
Plegridy
The Food and Drug Administration (FDA) approved PlegridyTM (peginterferon beta-1a injection) for the treatment of relapsing forms of multiple sclerosis. Source: FDA website
New Drug 08-15-14
Cerdelga
The Food and Drug Administration (FDA) approved CerdelgaTM (eliglustat capsules) for the treatment of certain adults with Gaucher disease type 1 disease. Source: FDA website
New Drug 08-19-14
Arnuity Ellipta
The Food and Drug Administration (FDA) approved ArnuityTM Ellipta® (fluticasone furoate oral inhalation powder) for the maintenance treatment of asthma as prophylactic therapy in individuals 12 years old or greater. Source: FDA website
New Drug 08-20-14
Afluria PharmaJet Stratis
The Food and Drug Administration (FDA) approved Afluria® PharmaJet Stratis® 0.5 mL Needle-Free Jet Injector (trivalent influenza vaccine injection) for influenza vaccination in individuals aged 18-64 years. Source: FDA website
New Drug 08-19-14
Zorvolex
The Food and Drug Administration (FDA) approved Zorvolex® (diclofenac capsules) for the management of osteoarthritis pain. Source: FDA website
New Drug 08-25-14
Promacta
The Food and Drug Administration (FDA) approved Promacta® (eltrombopag tablets) in individuals with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy. Source: FDA website
New Indication 08-26-14
Ilaris
TThe Food and Drug Administration (FDA) approved Ilaris® (canakinumab injection) for use in individuals with Tumor Necrosis Factor Receptor-Associated Periodic Syndrome (TRAPS), Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) and Familial Mediterranean Fever (FMF). Source: FDA website
New Indication 9/23/2016
Stelara
The Food and Drug Administration (FDA) approved Stelara® (ustekinumab injection) for the treatment of moderately to severely active Crohn’s disease in adults who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.Source: FDA website
New Indication 9/26/2016
Orkambi
The Food and Drug Administration (FDA) approved Orkambi® (lumacaftor/ivacaftor tablets) for use in children with cystic fibrosis aged 6-11 years who have 2 copies of the F508del mutation. Source: FDA website
New Indication 9/28/2016
Epaned
The Food and Drug Administration (FDA) approved Epaned® (enalapril maleate oral solution) for the treatment of hypertension in adults and children >1 month, to lower blood pressure. It is also indicated to treat symptomatic heart failure and asymptomatic left ventricular dysfunction. Source: FDA website
New Drug 9/23/2016
Direct-Acting Antivirals for Hepatitis C
The Food and Drug Administration (FDA) is warning about the risk of hepatitis B virus (HBV) becoming an active infection again in any individual who has a current or previous infection with HBV and is treated with certain direct-acting antiviral (DAA) medications for hepatitis C virus. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm Source: FDA website
Drug Warning 10/4/2016
Elelyso
The Food and Drug Administration (FDA) approved ElelysoTM (taliglucerase alfa injection) for long-term enzyme replacement therapy (ERT) in pediatric individuals with a confirmed diagnosis of Type 1 Gaucher disease. Source: FDA website
New Indication 08-28-14
Vimpat
The Food and Drug Administration (FDA) approved Vimpat® (lacosamide tablets, injection, and oral solution) as monotherapy in the treatment of partial-onset seizures in individuals with epilepsy aged > 17 years. Source: FDA website
New Indication 09-02-14
Epaned
The Food and Drug Administration (FDA) approved EpanedTM (enalapril maleate powder for oral solution) for treatment of symptomatic heart failure and treatment of asymptomatic left ventricular dysfunction. Source: FDA website
New Indication 09-08-14
Menactra
The Food and Drug Administration (FDA) approved Menactra® (meningococcal Groups A, C, Y, W-135 polysaccharide diphtheria toxoid conjugate vaccine injection) for booster vaccination against meningococcal disease in individuals aged 15-55 years. Source: FDA website
New Indication 09-08-14
Xtandi
The Food and Drug Administration (FDA) approved Xtandi® (enzalutamide capsules) in metastatic castration-resistant prostate cancer (CRPC) in men who have not yet received chemotherapy. Source: FDA website
New Indication 09-10-14
Triumeq
The Food and Drug Administration (FDA) approved Triumeq® (abacavir/dolutegravir/lamivudine tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection. Source: FDA website
New Drug 08-22-14
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of advanced or unresectable melanoma in individuals who are no longer responsive to other drugs. Source: FDA websitee
New Drug 09-04-14
Ferric Citrate
The Food and Drug Administration (FDA) approved Ferric Citrate for the control of serum phosphorus levels in individuals with chronic kidney disease on dialysis. A brand name is still to be determined. Source: FDA website
New Drug 09-05-14
Contrave
The Food and Drug Administration (FDA) approved Contrave® (naltrexone/bupropion extended-release tablets) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) > 30 kg/m2 (obese) or > 27 kg/m2 (overweight) in the presence of at least one weight-related comorbid condition. Source: FDA website
New Drug 09-11-14
Martin Avenue Pharmacy
Martin Avenue Pharmacy announced a voluntary recall of all in-date compounded sterile preparations due to a lack of assurance of sterility. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm412493.htm Source: FDA website
Drug Recall 09-02-14
Pharmacy Creations
Pharmacy Creations announced a voluntary recall of four lots of products due to potential non-sterility. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm413053.htm Source: FDA website
Drug Recall 09-06-14
Rixubis
The Food and Drug Administration (FDA) approved Rixubis® (coagulation factor IX [recombinant] injection) for routine prophylaxis, control, and prevention of bleeding episodes, and perioperative management in children with hemophilia B. Source: FDA website
New Indication 09-15-14
Stendra
The Food and Drug Administration (FDA) approved Stendra® (avanafil tablets) to be taken as early as approximately 15 minutes before sexual activity in the treatment of erectile dysfunction. Source: FDA website
New Indication 09-18-14
Otezla
The Food and Drug Administration (FDA) approved Otezla® (apremilast tablets) for the treatment of individuals with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. Source: FDA website
New Indication 09-23-14
Minivelle
The Food and Drug Administration (FDA) approved Minivelle® (estradiol 0.025 mg/day patch) for the prevention of postmenopausal osteoporosis. Source: FDA website
New Indication 09-24-14
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for reducing signs and symptoms, and achieving and maintaining clinical remission, in Crohn's disease for individuals 6 years old or greater when certain other treatments were inadequate. Source: FDA website
New Indication 09-25-14
HyQvia
The Food and Drug Administration (FDA) approved HyQvia® (immune globulin infusion 10% [human] with recombinant human hyaluronidase injection) for adults with primary immunodeficiency (PI). Source: FDA website
New Drug 09-15-14
Spiriva Respimat
The Food and Drug Administration (FDA) approved Spiriva® Respimat® (tiotropium bromide oral inhalation spray) for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Source: FDA website
New Drug 09-15-14
Movantik
The Food and Drug Administration (FDA) approved MovantikTM (naloxegol tablets) for the treatment of opioid-induced constipation in adults with chronic non-cancer pain. Source: FDA website
New Drug 09-16-14
Mucinex
RB announced a recall of certain lots of liquid bottles of Mucinex Fast-MAX cough and cold products due to incorrect labeling. Contact your healthcare provider with any questions. More details including affected products may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm444082.htm Source: FDA website
Drug Recall 04-22-15
Trulicity
The Food and Drug Administration (FDA) approved TrulicityTM (dulaglutide injection) to improve blood sugar control in adults with type 2 diabetes. Source: FDA website
New Drug 09-18-14
Tybost
The Food and Drug Administration (FDA) approved Tybost® (cobicistat tablets) to increase systemic exposure of atazanavir or darunavir in combination with other antiretroviral agents in the treatment of human immunodeficiency virus-1 (HIV-1) infection. Source: FDA website
New Drug 09-24-14
Tuzistra XR
The Food and Drug Administration (FDA) approved TuzistraTM (codeine polistirex/chlorpheniramine polistirex extended-release oral suspension) for the relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years or older. Source: FDA website
New Drug 05-01-15
Vitekta
The Food and Drug Administration (FDA) approved Vitekta® (elvitegravir tablets) in combination with a ritonavir-boosted protease inhibitor and with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults. Source: FDA website
New Drug 09-24-14
Taclonex Topical Suspension
The Food and Drug Administration (FDA) approved Taclonex® (calcipotriene/betamethasone dipropionate) Topical Suspension for the treatment of plaque psoriasis of the scalp in individuals aged 12-17 years. Source: FDA website
New Indication 09-30-14
Ozurdex
The Food and Drug Administration (FDA) approved Ozurdex® (dexamethasone intravitreal implant) for the treatment of diabetic macular edema (DME) in the general DME population. Source: FDA website
New Indication 09-29-14
Relistor
The Food and Drug Administration (FDA) approved Relistor® (methylnaltrexone bromide injection) for the treatment of opioid induced constipation in chronic pain unrelated to cancer. Source: FDA website
New Indication 09-29-14
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) in children aged 2 years and older. Source: FDA website
New Indication 10-06-14
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) for the treatment of macular edema following retinal vein occlusion (RVO), including macular edema following branch retinal vein occlusion (BRVO) in addition to macular edema following central retinal vein occlusion (CRVO). Source: FDA website
New Indication 10-07-14
Velcade
The Food and Drug Administration (FDA) approved Velcade® (bortezomib injection) for the treatment of mantle cell lymphoma (MCL) in previously untreated patients. Source: FDA website
New Indication 10-09-14
Xiaflex
The Food and Drug Administration (FDA) approved Xiaflex® (collagenase clostridium histolyticum injection) for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit. Source: FDA website
New Indication 10-21-14
Flublok
The Food and Drug Administration (FDA) approved Flublok® (trivalent recombinant influenza vaccine injection) for use in all adults aged 18 and older for active immunization against influenza virus subtypes A and B. Source: FDA website
New Indication 10-29-14
Embeda
The Food and Drug Administration (FDA) approved labeling for Embeda® (morphine sulfate/naltrexone extended-release capsules) to include abuse-deterrence studies. Embeda is indicated for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda was withdrawn from the market in March 2011 due to manufacturing issues. It will be re-introduced in early 2015. Source: FDA website
New Drug 10-20-14
Entresto
The Food and Drug Administration (FDA) approved EntrestoTM (sacubitril/valsartan tablets) to reduce the risk of cardiovascular death and hospitalization for heart failure in individuals with chronic heart failure and reduced ejection fraction. Source: FDA website
New Drug 07-07-15
Abilify Maintena
The Food and Drug Administration (FDA) approved Abilify Maintena® (aripiprazole extended-release injection) as a prefilled dual-chamber syringe for the treatment of schizophrenia. Source: FDA website
New Drug09-30-14
Iluvien
The Food and Drug Administration (FDA) approved Iluvien® (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema (DME) in individuals who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Source: FDA website
New Drug 09-29-14
Mitigare
The Food and Drug Administration (FDA) approved MitigareTM (colchicine capsules) for the prophylaxis of gout flares in adults. Source: FDA website
New Drug 09-30-14
Minocin
The Food and Drug Administration (FDA) approved MinocinTM (minocycline injection) with lower volume for administration for the treatment of infections due to susceptible strains of designated microorganisms. Source: FDA website
New Drug 04-20-15
Prepopik
The Food and Drug Administration (FDA) approved Prepopik® (sodium picosulfate/magnesium oxide/anhydrous citric acid) in a new cranberry flavor for cleansing of the colon as a preparation for colonoscopy in adults. Source: FDA website
New Drug 10-07-14
Uceris Rectal Foam
The Food and Drug Administration (FDA) approved Uceris® (budesonide rectal foam) for the induction of remission in individuals with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge. Source: FDA website
New Drug 10-08-14
Unapproved prescription ear drops
The Food and Drug Administration (FDA) announced it will take action against companies that manufacture and/or distribute certain unapproved prescription ear drops labeled to relieve ear pain, infection and inflammation. Contact your healthcare professional with questions. More details including affected ingredients may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453430.htm Source: FDA website
Drug Warning 07-01-15
Sotylize
The Food and Drug Administration (FDA) approved SotylizeTM(sotalol oral solution) for the treatment of ventricular arrhythmias and the maintenance of normal sinus rhythm in individuals with a history of symptomatic atrial fibrillation/flutter. Source: FDA website
New Drug 10-23-14
Obizur
The Food and Drug Administration (FDA) approved ObizurTM (antihemophilic factor [recombinant], porcine sequence) for the treatment of bleeding episodes in adults with acquired hemophilia A. Source: FDA website
New Drug 10-24-14
Trumenba
The Food and Drug Administration (FDA) approved Trumenba® (meningococcal vaccine group B injection) to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25 years. Source: FDA website
New Drug 10-29-14
Tuxarin ER
The Food and Drug Administration (FDA) approved Tuxarin® ER (chlorpheniramine/codeine) oral formulation for the treatment of cough and cold symptoms. Source: FDA website
New Drug 07-01-15
Xigduo XR
The Food and Drug Administration (FDA) approved XidguoTM XR (dapagliflozin/metformin tablets) as adjunct treatment to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. Source: FDA website
New Drug 10-30-14
Akynzeo
The Food and Drug Administration (FDA) approved Akynzeo® (netupitant/palonosetron capsules) for the prevention of chemotherapy-induced nausea and vomiting. Source: FDA website
New Drug 10-10-14
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (ledipasvir/sofosbuvir tablets) for the treatment of chronic hepatitis C genotype 1 infection in adults. Source: FDA website
New Drug 10-10-14
Esbriet
The Food and Drug Administration (FDA) approved Esbriet® (pirfenidone capsules) for the treatment of idiopathic pulmonary fibrosis. Source: FDA website
New Drug 10-15-14
Ofev
The Food and Drug Administration (FDA) approved Ofev® (nintedanib capsules) for the treatment of idiopathic pulmonary fibrosis. Source: FDA website
New Drug 10-15-14
Naproxen sodium
Contract Packaging Resources announced a voluntary recall of Assured brand Naproxen sodium tablets due to some cartons containing bottles of ibuprofen, a different pain reliever. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419769.htm Source: FDA website
Drug Recall 10-22-14
Lidocaine
Hospira announced a voluntary recall of one lot of 1% Lidocaine HCL injection 10 mg/mL, 30 mL single-dose, preservative-free vials due to report of particulate in a single unit. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419322.htm Source: FDA website
Drug Recall 10-17-14
Cyramza
The Food and Drug Administration (FDA) approved CyramzaTM (ramucirumab injection) for use in combination with irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) for the treatment of individuals with metastatic colorectal cancer (mCRC) whose disease has progressed on a first line bevacizumab, oxaliplatin, and fluoropyrimidine containing regimen. Source: FDA website
New Indication 04-24-15
Olysio and Sovaldi
The Food and Drug Administration (FDA) approved Olysio® (simeprevir capsules) for use in combination with Sovaldi® (sofosbuvir tablets) for once-daily treatment in individuals with hepatitis C genotype 1. Source: FDA website
New Indication 11-06-14
Invega Sustenna
The Food and Drug Administration (FDA) approved Invega® Sustenna® (paliperidone palmitate injection) as either monotherapy or adjunctive therapy in the once-monthly treatment of schizoaffective disorder. Source: FDA website
New Indication 11-13-14
Avastin
The Food and Drug Administration (FDA) approved Avastin® (bevacizumab injection) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer. Source: FDA website
New Indication 11-14-14
Somatuline Depot
The Food and Drug Administration (FDA) approved Somatuline® Depot (lanreotide injection) as a prefilled, low-volume syringe that supports full-dose delivery with no reconstitution needed for the treatment of acromegaly. Source: FDA website
New Drug 11-06-14
Vasostrict
The Food and Drug Administration (FDA) approved VasostrictTM (vasopressin injection) to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. This is the first vasopressin injection product to receive an approval from the FDA. Source: FDA website
New Drug 11-12-14
Lemtrada
The Food and Drug Administration (FDA) approved LemtradaTM (alemtuzumab injection) for the treatment of relapsing forms of multiple sclerosis (MS). Source: FDA website.
New Drug 11-17-14
Hysingla ER
The Food and Drug Administration (FDA) approved HysinglaTM ER (hydrocodone extended-release tablets) for the treatment of severe pain that requires daily long-term opioid treatment and for which other treatment options are inadequate. Source: FDA website
New Drug 11-20-14
Onexton
The Food and Drug Administration (FDA) approved OnextonTM (clindamycin phosphate/benzoyl peroxide gel) for the once-daily treatment of comedonal and inflammatory acne in individuals ages 12 years and older. Source: FDA website
New Drug 11-25-14
Kitabis Pak (tobramycin inhalation solution and nebulizer)
The Food and Drug Administration (FDA) approved KitabisTM Pak (tobramycin inhalation solution and nebulizer) approved for individuals with cystic fibrosis ages 6 years and older with Pseudomonas aeruginosa. Source: FDA website
New Drug 12-03-14
Trezix
The Food and Drug Administration (FDA) approved TrezixTM (acetaminophen/caffeine/dihydrocodeine bitartrate capsules) for the management of moderate to moderately severe pain. Source: FDA website
New Drug 12-05-14
Blincyto
The Food and Drug Administration (FDA) approved BlincytoTM (blinatumomab injection) for the treatment of Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL). Source: FDA website
New Drug 12-03-14
Breo Ellipta
The Food and Drug Administration (FDA) approved Breo TM Ellipta (fluticasone furoate/vilanterol oral inhalation) for the treatment of asthma in individuals aged 18 years and older. Source: FDA website
New Indication 04-30-15
Jakafi
The Food and Drug Administration (FDA) approved Jakafi®(ruxolitinib tablets) for the treatment of polycythemia vera (PV) in individuals who have had an inadequate response to or are intolerant of hydroxyurea. Source: FDA website
New Indication 12-04-14
Priftin
The Food and Drug Administration (FDA) approved Priftin® (rifapentine tablets) in combination with isoniazid for the treatment of latent tuberculosis infection in individuals ages 2 years and older at high risk of progression to tuberculosis disease. Source: FDA website
New Indication 12-04-14
Highly Concentrated Potassium Chloride
Baxter International announced a voluntary recall of one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL due to a complaint of mislabeling of the overpouch. Contact your healthcare professional with any questions. Details including affected lot number may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424276.htm. Source: FDA website
Drug Recall 11-21-14
Tecfidera
The Food and Drug Administration (FDA) announced that a patient with multiple sclerosis (MS) who was being treated with Tecfidera developed a rare brain infection called progressive multifocal leukoencephalopathy (PML) and later died. The patient was not taking any other drugs associated with PML. The prescribing information will be updated to reflect this case report. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424752.htm
Drug Warning 11-25-14
Xgeva
The Food and Drug Administration (FDA) approved XgevaTM (denosumab injection) for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Source: FDA website.
New Indication 12-08-14
Naftin
The Food and Drug Administration (FDA) approved Naftin® (naftifine 2% cream and gel) for the treatment of interdigital type tinea pedis in individuals aged 12-17 years. Source: FDA website.
New Indication 12-08-14
Cyramza
The Food and Drug Administration (FDA) approved Cyramza® (ramucirumab injection) for the treatment of individuals with metastatic non-small cell lung cancer (NSCLC).
New Indication 12-12-14
Somatuline Depot
The Food and Drug Administration (FDA) approved Somatuline® Depot (lanreotide injection) for the treatment of gastroenteropancreatic neuroendocrine tumors in adults with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival. Source: FDA website
New Indication 12-29-14
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets) for use in individuals with cystic fibrosis (CF) ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Source: FDA website
New Indication 12-29-14
Natroba
The Food and Drug Administration (FDA) approved an expanded age range for NatrobaTM (spinosad topical suspension) to include children 6 months and older who have head lice. Source: FDA website
New Indication 01-06-15
Dyloject
The Food and Drug Administration (FDA) approved DylojectTM (diclofenac sodium injection) for the management of mild to moderate pain in adults, and for moderate to severe pain alone or in combination with opioid analgesics. Source: FDA website
New Drug 12-30-14
Signifor LAR
The Food and Drug Administration (FDA) approved Signifor® LAR (pasireotide diaspartate long-acting release injection) for the treatment of individuals with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. Source: FDA website
New Drug 12-16-14
Soolantra
The Food and Drug Administration (FDA) approved Soolantra® (ivermectin topical cream) for the treatment of inflammatory lesions of rosacea. Source: FDA website
New Drug 12-23-14
Saxenda
The Food and Drug Administration (FDA) approved Saxenda® (liraglutide injection) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥30kg/m2 (obese) or ≥27kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia). Source: FDA website
New Drug 12-23-14
Namzaric
The Food and Drug Administration (FDA) approved NamzaricTM (memantine extended-release/donepezil capsules) for the treatment of moderate to severe Alzheimer's dementia in individuals stabilized on memantine and donepezil. Source: FDA website
New Drug 12-29-14
Gardasil 9
The Food and Drug Administration (FDA) approved Gardasil® 9 (9-valent human papillomavirus types, recombinant vaccine injection) for the prevention of cervical, vulvar, vaginal, anal cancers, and for the prevention of genital warts caused by nine types of human papillomavirus (HPV) in females 9-26 years old and males 9-15 years old. Source: FDA website
New Drug 12-10-14
Fluzone Intradermal Quadrivalent
The Food and Drug Administration (FDA) approved Fluzone® Intradermal Quadrivalent (seasonal influenza virus quadrivalent vaccine injection) for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses for adults aged 18-64. Source: FDA website
New Drug 12-12-14
QNASL
The Food and Drug Administration (FDA) approved QNASLTM (beclomethasone dipropionate nasal spray) for the treatment of nasal symptoms associated with allergic rhinitis in children 4-11 years old. This is a non-aqueous hydrofluoroalkane (HFA) nasal product. Source: FDA website
New Drug 12-19-14
Xtoro
The Food and Drug Administration (FDA) approved Xtoro® (finafloxacin otic suspension) for the treatment of acute otitis externa (swimmer's ear). Source: FDA website
New Drug 12-17-14
Lynparza
The Food and Drug Administration (FDA) approved LynparzaTM (olaparib capsules) for the treatment of advanced ovarian cancer. Source: FDA website
New Drug 12-19-14
Zerbaxa
The Food and Drug Administration (FDA) approved ZerbaxaTM (ceftolozane/tazobactam injection) for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by susceptible Gram-negative bacteria. Source: FDA website
New Drug 12-19-14
Rapivab
The Food and Drug Administration (FDA) approved RapivabTM (peramivir injection) for the treatment of acute uncomplicated influenza in adults who have been symptomatic for no more than two days. Source: FDA website
New Drug 12-19-14
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with unresectable or metastatic melanoma. Source: FDA website
New Drug 12-22-14
Viekira Pak
The Food and Drug Administration (FDA) approved Viekira PakTM (ombitasvir/paritaprevir/ritonavir tablets co-packaged with dasabuvir tablets) for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. Source: FDA website
New Drug 12-19-14
Ziprasidone
The Food and Drug Administration (FDA) is warning that the antipsychotic drug ziprasidone (marketed under the brand name Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to other parts of the body. The drug labeling will be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm426624.htm Source: FDA website
Drug Warning 12-11-14
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib capsules) for use in previously treated individuals with Waldenstrom's macroglobulinemia. Source: FDA website
New Indication 01-29-15
Rytary
The Food and Drug Administration (FDA) approved Rytary™ (carbidopa/levodopa extended-release capsules) for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication. Source: FDA website
New Drug 01-08-15
Duopa
The Food and Drug Administration (FDA) approved Duopa® (carbidopa/levodopa enteral suspension) for the treatment of motor fluctuations for people with advanced Parkinson's disease. Source: FDA website
New Drug 01-12-15
Prestalia
The Food and Drug Administration (FDA) approved Prestalia® (amlodipine/perindopril tablets) for the treatment of hypertension. Source: FDA website
New Drug 01-21-15
Bexsero
The Food and Drug Administration (FDA) approved Bexsero® (meningococcal group B vaccine injection) for active immunization to prevent invasive meningitis B in individuals aged 10-25 years. Source: FDA website
New Drug 01-26-15
Natpara
The Food and Drug Administration (FDA) approved Natpara® (parathyroid hormone injection) as adjunct to calcium and vitamin D to control hypocalcemia in individuals with hypoparathyroidism. Source: FDA website
New Drug 01-26-15
Triferic
The Food and Drug Administration (FDA) approved Triferic™ (soluble ferric pyrophosphate solution) as an iron replacement product to maintain hemoglobin in adults with hemodialysis dependent chronic kidney disease (CKD). Triferic is introduced into bicarbonate concentrate at the dialysis clinic and then mixed into the dialysate. Source: FDA website
New Drug 01-26-15
Prezcobix
The Food and Drug Administration (FDA) approved Prezcobix™ (darunavir/cobicistat tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in combination with other antiretroviral agents for treatment-naïve and treatment experienced adults with no darunavir resistance-associated substitutions. Source: FDA website
New Drug 01-30-15
Evotaz
The Food and Drug Administration (FDA) approved Evotaz™ (atazanavir/cobicistat tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in adults. Source: FDA website
New Drug 01-30-15
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx™ (secukinumab injection) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Source: FDA website
New Drug 01-21-15
Corlanor
The Food and Drug Administration (FDA) approved Corlanor™ (ivabradine tablets) to reduce the risk of hospitalization for certain individuals with chronic heart failure who either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. Source: FDA website
New Drug 04-15-15
Savaysa
The Food and Drug Administration (FDA) approved Savaysa™ (edoxaban tablets) for the reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation (NVAF), treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of therapy with an injectable anticoagulant. Source: FDA website
New Drug 01-08-15
Prescription and over-the-counter pain medicines
The Food and Drug Administration (FDA) has responded to concerns regarding the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. They have evaluated the data and determined it is too limited to make any recommendations at this time. The FDA states that the use of pain medicines during pregnancy should be carefully considered. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm429604.htm Source: FDA website
Drug Warning 01-09-15
Vyvanse
The Food and Drug Administration (FDA) approved Vyvanse® (lisdexamfetamine dimesylate capsules) for the treatment of binge-eating disorder in adults. Source: FDA website
New Indication 02-02-15
Glyxambi
The Food and Drug Administration (FDA) approved Glyxambi® (empagliflozin/linagliptin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when both empagliflozin and linagliptin are appropriate treatments. Source: FDA website
New Drug 01-30-15
Zohydro ER
The Food and Drug Administration (FDA) approved Zohydro® ER (hydrocodone bitartrate extended-release capsules) with abuse deterrent properties for the management of pain. Source: FDA website
New Drug 01-30-15
Ibrance
The Food and Drug Administration (FDA) approved Ibrance® (palbociclib capsules) for the treatment of estrogen receptor positive, human epidermal growth factor receptor (HER) 2 negative breast cancer in combination with letrozole. Source: FDA website
New Drug 02-03-15
Pazeo
The Food and Drug Administration (FDA) approved Pazeo™ (olopatadine hydrochloride ophthalmic solution) for the treatment of ocular itching associated with allergic conjunctivitis. Source: FDA website
New Drug 02-02-15
Banzel
The Food and Drug Administration (FDA) approved Banzel® (rufinamide tablets) as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric individuals aged 1-4 years old. Source: FDA website
New Indication 02-13-15
Revlimid
The Food and Drug Administration (FDA) approved Revlimid® (lenalidomide capsules) for expanded use in newly diagnosed multiple myeloma in combination with dexamethasone. Source: FDA website
New Indication 02-18-15
Lucentis
The Food and Drug Administration (FDA) approved Lucentis® (ranibizumab ophthalmic injection) for the treatment of diabetic retinopathy in individuals with diabetic macular edema (DME). Source: FDA website
New Indication 02-18-15
Dutrebis
The Food and Drug Administration (FDA) approved Dutrebis™ (lamivudine/raltegravir tablets) in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection. Source: FDA website
New Drug 02-06-15
Lenvima
The Food and Drug Administration (FDA) approved Lenvima™ (lenvatinib capsules) for the treatment of individuals with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine (RAI) therapy. Source: FDA website
New Drug 02-13-15
Lenvima
The Food and Drug Administration (FDA) approved Lenvima™ (lenvatinib capsules) for the treatment of individuals with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine (RAI) therapy. Source: FDA website
New Drug 02-13-15
Dymista
The Food and Drug Administration (FDA) approved Dymista™ (azelastine/fluticasone propionate nasal spray) for the relief of symptoms of seasonal allergic rhinitis (SAR) in individuals ages 6-11 who require treatment with both components. Source: FDA website
New Indication 02-20-15
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for individuals with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Source: FDA website
New Indication 02-04-15
Toujeo
The Food and Drug Administration (FDA) approved Toujeo® (insulin glargine injection) for the treatment of type 1 and type 2 diabetes. Source: FDA website
New Drug 02-25-15
Elepsia XR
The Food and Drug Administration (FDA) approved Elepsia XR™ (levetiracetam extended-release tablets) for adjunctive therapy in the treatment of partial onset seizures in individuals 12 years of age and older with epilepsy. Source: FDA website
New Drug 02-25-15
Liletta
The Food and Drug Administration (FDA) approved Liletta™ (levonorgestrel-releasing intrauterine system) approved for the prevention of pregnancy for up to 3 years. Source: FDA website
New Drug 02-27-15
Avycaz
The Food and Drug Administration (FDA) approved Avycaz™ (ceftazidime/avibactam injection) for complicated intra-abdominal infections in combination with metronidazole. It is also approved for complicated urinary tract infections. Source: FDA website
New Drug 02-25-15
Zarxio
The Food and Drug Administration (FDA) approved Zarxio® (filgrastim injection) for neutropenia in individuals with cancer receiving myelosuppressive chemotherapy, in individuals with acute myeloid leukemia receiving induction or consolidation chemotherapy, in individuals with cancer undergoing bone marrow transplantation, in individuals undergoing autologous peripheral blood progenitor cell collection and therapy, and in individuals with severe chronic neutropenia. Zarxio is the first biosimilar product approved in the United States. Source: FDA website
New Drug 03-06-15
Farydak
The Food and Drug Administration (FDA) approved Farydak® (panobinostat capsules) for the treatment of individuals with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulator. Farydak is used in combination with bortezomib and dexamethasone. Source: FDA website
New Drug 02-23-15
Cresemba
The Food and Drug Administration (FDA) approved Cresemba® (isavuconazonium sulfate capsules and injection) for adults with invasive aspergillosis and mucormycosis. Source: FDA website
New Drug 03-06-15
Testosterone products
The Food and Drug Administration (FDA) is requiring manufacturers of all approved prescription testosterone products to update their labeling regarding possible increased risk of heart attack and stroke with these products. In addition, labeling should clarify approved uses of these medications with cautions about using for low testosterone due to aging. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm436280.htm Source: FDA website
Drug Warning 03-03-15
Saphris
The Food and Drug Administration (FDA) approved Saphris®(asenapine sublingual tablets) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric individuals aged 10-17 years. Source: FDA website
New Indication 03-13-15
Kalydeco
The Food and Drug Administration (FDA) approved Kalydeco® (ivacaftor tablets and oral granules) for use in children ages 2-5 with cystic fibrosis (CF) who have one of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene). Source: FDA website
New Indication 03-18-15
Unituxin
The Food and Drug Administration (FDA) approved Unituxin™ (dinutuximab injection) for pediatric individuals with high-risk neuroblastoma for use as part of a multimodal regimen including surgery, chemotherapy and radiation therapy for individuals who achieved at least a partial response to prior first-line multiagent, multimodality therapy. Source: FDA website
New Drug 03-10-15
Cholbam
The Food and Drug Administration (FDA) approved Cholbam® (cholic acid capsules) for the treatment of bile acid synthesis disorders and peroxisomal disorders. Source: FDA website
New Drug 03-17-15
Codeine cough and cold products
The Food and Drug Administration (FDA) is investigating the safety of using codeine-containing medicines to treat coughs and colds in children less than 18 years of age due to the potential for serious adverse events including slowed or difficult breathing. Final conclusions and recommendations will be communicated when the review is complete. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm453379.htm Source: FDA website
Drug Warning 07-01-15
Chantix
The Food and Drug Administration (FDA) issued a warning that the smoking cessation drug Chantix® (varenicline tablets) can change the way people react to alcohol with some experiencing increased intoxicating effects. The label will be updated to include this potential alcohol interaction. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm437415.htm Source: FDA website
Drug Warning 03-09-15
Over-the-counter asthma products
The Food and Drug Administration (FDA) is warning consumers not to rely on over-the-counter (OTC) asthma products labeled as homeopathic. These products have not been evaluated by the FDA and may pose potential health risks. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439014.htm Source: FDA website
Drug Warning 03-19-15
Eylea
The Food and Drug Administration (FDA) approved Eylea® (aflibercept injection) for the treatment of diabetic retinopathy in individuals with diabetic macular edema (DME). Source: FDA website
New Indication 03-25-15
Qudexy XR
The Food and Drug Administration (FDA) approved Qudexy™ XR (topiramate extended-release capsules) as initial monotherapy in individuals 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. Source: FDA website
New Indication 04-02-15
Quadracel
The Food and Drug Administration (FDA) approved Quadracel® (DTaP-poliovirus vaccine injection) for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis for children aged 4 to 6 years of age. Source: FDA website
New Drug 03-25-15
ProAir RespiClick
The Food and Drug Administration (FDA) approved ProAir® RespiClick (albuterol sulfate breath-actuated dry-powder oral inhalation) for the treatment of acute asthma symptoms. Source: FDA website
New Drug 04-01-15
Jadenu
The Food and Drug Administration (FDA) approved Jadenu™ (deferasirox tablets) for the treatment of chronic iron overload due to blood transfusions in individuals 2 years and older and for chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients greater than 10 years and older. Source: FDA website
New Drug 03-31-15
Mammograms
The Food and Drug Administration (FDA) is alerting individuals who had mammograms at Coastal Diagnostic Center in Pismo Beach, CA anytime on or after February 24, 2013 about possible problems with mammogram quality. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm445181.htm Source: FDA website
Drug Warning 04-30-15
Zyprexa Relprevv
The Food and Drug Administration (FDA) has concluded a review of a study on schizophrenia drug Zyprexa® Relprevv™ (olanzapine pamoate injection) to determine the cause of elevated levels of the drug in two individuals who died. The results were inconclusive. The FDA is not recommending any changes to current prescribing at this time. Patients should not stop receiving treatment without first talking to their health care provider. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm439472.htm Source: FDA website
Drug Warning 03-23-15
Prescription Center Pharmacy
The Food and Drug Administration (FDA) is joining the North Carolina Board of Pharmacy to urge health care professionals and consumers not to use products made and distributed by the Prescription Center Pharmacy in Fayetteville, North Carolina due to a lack of sterility assurance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm441001.htm Source: FDA website
Drug Warning 04-02-15
Neupogen
The Food and Drug Administration (FDA) approved Neupogen® (filgrastim injection) to increase survival in individuals acutely exposed to myelosuppressive doses of radiation (hemopoietic syndrome of acute radiation syndrome). Source: FDA website
New Indication 04-06-15
Non-aspirin, non-steroidal anti-inflammatory drugs (NSAIDs)
The Food and Drug Administration (FDA) announced it is strengthening an existing label warning that NSAIDs increase the risk of a heart attack or stroke. Contact your healthcare professional with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm454141.htm Source: FDA website
Drug Warning 04-06-15
Avelox
The Food and Drug Administration (FDA) approved Avelox® (moxifloxacin tablets) for the prevention and treatment of pneumonic plague and septicemic plague in adults. Source: FDA website
New Indication 05-08-15
Treximet
The Food and Drug Administration (FDA) approved Treximet® (sumatriptan/naproxen tablets) for the treatment of acute migraine with or without aura in individuals 12 years or older. Source: FDA website
New Indication 05-15-15
Aptensio XR
The Food and Drug Administration (FDA) approved Aptensio XR™ (methylphenidate extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD). Source: FDA website
New Drug 04-17-15
Stiolto Respimat
The Food and Drug Administration (FDA) approved Stiolto™ Respimat® (tiotropium bromide/olodaterol inhalation spray) for the long-term maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Source: FDA website
New Drug 05-26-15
Ixinity
The Food and Drug Administration (FDA) approved Ixinity® (coagulation factor IX recombinant injection) for the prevention of bleeding in individuals with hemophilia B. Source: FDA website
New Drug 04-29-15
Trinza
The Food and Drug Administration (FDA) approved Trinza™ (paliperidone palmitate extended-release injectable suspension) for the treatment of schizophrenia in adults. Trinza requires administration only four times per year. Source: FDA website
New Drug 05-19-15
Sodium-glucose cotransporter-2 (SGLT2) inhibitors
The Food and Drug Administration (FDA) is warning that SGLT2 inhibitors for diabetes (canagliflozin, dapagliflozin, empagliflozin) may lead to ketoacidosis, a condition where the body produces high levels of blood acids called ketones that may lead to hospitalization. The agency will determine if changes are needed in the prescribing information. Contact your healthcare provider with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm446994.htm Source: FDA website
Drug Warning 05-15-15
Rapamune
The Food and Drug Administration (FDA) approved Rapamune® (sirolimus tablets and oral solution) to stabilize lung function in individuals with lymphangioleiomyomatosis (LAM). Source: FDA website
New Indication 05-29-15
Qudexy XR
The Food and Drug Administration (FDA) approved Qudexy™ XR (topiramate extended-release capsules) for use as initial monotherapy in individuals 2 years of age and older with partial-onset seizures or primary generalized tonic-clonic seizures. Source: FDA website
New Indication 06-01-15
Xifaxan
The Food and Drug Administration (FDA) approved Xifaxan® 550 mg (rifaximin tablets) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. Source: FDA website
New Indication 05-27-15
Viberzi
The Food and Drug Administration (FDA) approved Viberzi™ (eluxadoline tablets) for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. Source: FDA website
New Drug 05-27-15
Soft tissue fillers
The Food and Drug Administration (FDA) reviewed data that suggests unintentional injection of soft tissue fillers (products FDA-approved to reduce the appearance of wrinkles) into blood vessels in the face can result in rare but serious injury. The FDA is working with manufacturers to update product labeling. Contact your healthcare provider with questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm448439.htm Source: FDA website
Drug Warning 05-28-15
Promacta
The Food and Drug Administration (FDA) approved Promacta® (eltrombopag tablets) for the treatment of children 6 years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Source: FDA website
New Indication 06-11-15
Zomig
The Food and Drug Administration (FDA) approved Zomig® (zolmitriptan nasal spray) for use in individuals 12 years and older for the acute treatment of migraine with or without aura. Source: FDA website
New Indication 06-16-15
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel tablets) as an adjunctive treatment of primary generalized tonic-clonic seizures for individuals aged 12 years or older with epilepsy. Source: FDA website
New Indication 06-22-15
Kengreal
The Food and Drug Administration (FDA) approved Kengreal™ (cangrelor injection) as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in individuals who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor. Source: FDA website
New Drug 06-22-15
Daytrana
The Food and Drug Administration (FDA) is warning that permanent loss of skin color may occur with the use of Daytrana® (methylphenidate transdermal system) for attention deficit hyperactivity disorder (ADHD). The product labeling has been updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm452595.htm Source: FDA website
Drug Warning 06-24-15
Kyprolis
The Food and Drug Administration (FDA) approved Kyprolis®(carfilzomib injection) in combination with lenalidomide and dexamethasone for the treatment of individuals with relapsed multiple myeloma who have received 1-3 prior lines of therapy. Source: FDA website
New Indication 07-24-15
Dysport
The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) for the treatment of upper limb spasticity in adults. Source: FDA website
New Indication 07-17-15
Envarsus XR
The Food and Drug Administration (FDA) approved Envarsus® XR (tacrolimus extended-release tablets) for prevention of organ rejection in individuals with kidney transplants. Source: FDA website
New Drug 07-10-15
Epiduo Forte
The Food and Drug Administration (FDA) approved Epiduo® Forte (adapalene/benzoyl peroxide gel) for the once-daily topical treatment of acne vulgaris. Source: FDA website
New Drug 07-16-15
Finacea
The Food and Drug Administration (FDA) approved Finacea® (azelaic acid 15% foam) to treat inflammatory papules and pustules of mild to moderate rosacea. Source: FDA website
New Drug 07-31-15
Rexulti
The Food and Drug Administration (FDA) approved Rexulti® (brexpiprazole tablets) for schizophrenia and adjunctive treatment for major depressive disorder. Source: FDA website
New Drug 07-10-15
Iressa
The Food and Drug Administration (FDA) approved Iressa® (gefitinib tablets) as first-line treatment for individuals with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. Source: FDA website
New Drug 07-13-15
Odomzo
The Food and Drug Administration (FDA) approved Odomzo® (sonidegib capsules) for the treatment of adults with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. Source: FDA website
New Drug 07-24-15
Praluent
The Food and Drug Administration (FDA) approved Praluent® (alirocumab injection) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low density lipoprotein cholesterol (LDL-C). Source: FDA website
New Drug 07-24-15
Daklinza
The Food and Drug Administration (FDA) approved Daklinza® (daclatasvir tablets) in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) genotype 3 infection. Source: FDA website
New Drug 07-24-15
Technivie
The Food and Drug Administration (FDA) approved Technivie™ (ombitasvir/paritaprevir/ritonavir tablets) in combination with ribavirin for the treatment of adults with genotype 4 chronic hepatitis C virus (HCV) infection who do not have cirrhosis. Source: FDA website
New Drug 07-24-15
Moses Lake Professional Pharmacy
Moses Lake Professional Pharmacy announced a voluntary recall of human and veterinary sterile compounded drugs which are unexpired due to lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm455931.htm Source: FDA website
Drug Warning 07-24-15
Zubsolv
The Food and Drug Administration (FDA) approved Zubsolv® (buprenorphine/naloxone sublingual tablets) for the induction of buprenorphine maintenance therapy in individuals with opioid dependence. Source: FDA website
New Indication 08-11-15
Gammaplex
The Food and Drug Administration (FDA) approved Gammaplex® (immune globulin 5% liquid for injection) for pediatric individuals 2 years of age and older who have primary humoral immunodeficiencies. Source: FDA website
New Indication 08-06-15
Wilate
The Food and Drug Administration (FDA) approved Wilate® (coagulation factor VIII injection) for the prevention of excessive bleeding during and after minor and major surgery in adult and pediatric individuals with von Willebrand disease. Source: FDA website
New Indication 08-13-15
Oxycontin
The Food and Drug Administration (FDA) approved Oxycontin® (oxycodone extended-release tablets) for individuals age 11 and older with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Source: FDA website
New Indication 08-14-15
Spritam
The Food and Drug Administration (FDA) approved Spritam® (levetiracetam tablets) as adjunctive therapy in the treatment of partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in individuals with epilepsy. This is the first 3D printed drug product approved by the FDA. Source: FDA website
New Drug 08-03-15
Keveyis
The Food and Drug Administration (FDA) approved KeveyisTM (dichlorphenamide tablets) for the treatment of primary hyperkalemic and hypokalemic periodic paralysis. Source: FDA website
New Drug 08-10-15
Hydrochlorothiazide
Unichem Pharmaceuticals announced a voluntary recall of one lot of Hydrochlorothiazide tablets 25 mg due to the identification of a Clopidogrel tablet found in a bottle of the product. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm456881.htm Source: FDA website
Drug Recall 07-31-15
Procysbi
The Food and Drug Administration (FDA) approved Procysbi® (cysteamine bitartrate delayed-release capsules) to treat children 2-6 years of age with nephropathic cystinosis. Source: FDA website
New Indication 08-17-15
Adcetris
The Food and Drug Administration (FDA) approved Adcetris® (brentuximab vedotin injection) for the treatment of individuals with classic Hodgkin lymphoma (HL) at high risk of relapse or progression post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. Source: FDA website
New Indication 08-18-15
Promacta
The Food and Drug Administration (FDA) approved Promacta® (eltrombopag tablets) for the treatment of thrombocytopenia in children > 1 year of age with chronic immune thrombocytopenia (ITP) who have not achieved an adequate response to corticosteroids, immunoglobulins, or splenectomy. Source: FDA website
New Indication 08-24-15
Edurant
The Food and Drug Administration (FDA) approved Edurant® (rilpivirine tablets) for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection in treatment naïve pediatric individuals from ages 12-18 years. Source: FDA website
New Indication 08-27-15
Aptiom
The Food and Drug Administration (FDA) approved Aptiom® (eslicarbazepine acetate tablets) as monotherapy for the treatment of partial-onset seizures. Source: FDA website
New Indication 08-28-15
Emend
The Food and Drug Administration (FDA) approved Emend® (aprepitant capsules) to include individuals 12-17 years old and individuals < 12 years old who weigh 30 kg or greater for the prevention of chemotherapy-induced nausea and vomiting (CINV). Source: FDA website
New Indication 09-02-15
Brilinta
The Food and Drug Administration (FDA) approved Brilinta® (ticagrelor tablets) at a new 60 mg dose to be used in individuals with a history of heart attack beyond the first year. Source: FDA website
New Indication 09-03-15
Synjardy
The Food and Drug Administration (FDA) approved Synjardy® (empagliflozin/metformin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, who are not adequately controlled on a regimen containing empagliflozin or metformin, or in individuals already being treated with both empagliflozin and metformin. Source: FDA website
New Drug 08-27-15
Addyi
The Food and Drug Administration (FDA) approved AddyiTM (flibanserin tablets) for the treatment of hypoactive sexual desire disorder in premenopausal women. Source: FDA website
New Drug 08-18-15
Repatha
The Food and Drug Administration (FDA) approved RepathaTM (evolocumab injection) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous or homozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of low density lipoprotein cholesterol (LDL-C). Source: FDA website
New Drug 08-28-15
Varubi
The Food and Drug Administration (FDA) approved VarubiTM (rolapitant tablets) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy. Source: FDA website
New Drug 09-01-15
Picato
The Food and Drug Administration (FDA) is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel for actinic keratosis. Updates to the drug label will be made. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm459311.htm Source: FDA website
Drug Warning 08-21-15
Mammograms at Boston Diagnostic Imaging
The Food and Drug Administration (FDA) is alerting individuals who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm458677.htm Source: FDA website
Drug Warning 08-17-15
Dipeptidyl peptidase-4 (DPP-4) Inhibitors
The Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin (DDP-4 inhibitors) may cause joint pain that can be severe and disabling. An update has been made to the labeling of all medicines in this drug class. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460238.htm Source: FDA website
Drug Warning 08-28-15
Allergan ophthalmic products
Allergan announced a voluntary recall of specific lots of Refresh Lacri-Lube, Refresh P.M., FML 0.1%, and Blephamide due to the presence of particulate matter. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm459496.htm Source: FDA website
Drug Recall 08-25-15
OmniPod insulin management system
Insulet Corporation announced a voluntary recall of 40,846 boxes of the OmniPod Insulin Management System due to the possibility that some of the pods may have a higher rate of failure than Insulet's current manufacturing standards. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm460197.htm Source: FDA website
Drug Recall 08-28-15
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of moderate to severe hidradenitis suppurativa (HS). Source: FDA website
New Indication 09-11-15
Delzicol
The Food and Drug Administration (FDA) approved DelzicolTM (mesalamine delayed-release capsules) for the treatment of mildly to moderately active ulcerative colitis in individuals 5 years of age and older. Source: FDA website
New Indication 09-11-15
Spiriva Respimat
The Food and Drug Administration (FDA) approved Spiriva® Respimat® (tiotropium bromide oral inhalation) for the long-term maintenance treatment of asthma in individuals aged 12 years and older. Source: FDA website
New Indication 09-15-15
Durlaza
The Food and Drug Administration (FDA) approved DurlazaTM (aspirin extended-release capsules) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (MI). Source FDA website
New Drug 09-08-15
Nuwiq
The Food and Drug Administration (FDA) approved Nuwiq® (recombinant antihemophilic factor injection) for the treatment of hemophilia A in adults and children 2 years and older. Source: FDA website
New Drug 09-15-15
Xuriden
The Food and Drug Administration (FDA) approved XuridenTM (uridine triacetate oral granules) for the treatment of hereditary orotic aciduria. Source: FDA website
New Drug 09-08-15
Vraylar
The Food and Drug Administration (FDA) approved VraylarTM (cariprazine capsules) for the treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults. Source: FDA website
New Drug 09-17-15
Medistat RX
The Food and Drug Administration (FDA) announced a voluntary recall by Medistat RX of all non-expired drug products produced for sterile use due to possible contamination. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm461850.htm Source: FDA website
Drug Recall 09-10-15
Clozapine
The Food and Drug Administration (FDA) is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia drug clozapine in order to address continuing safety concerns about a serious blood condition called severe neutropenia. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm462229.htm Source: FDA website
Drug Warning 09-15-15
Invokana and Invokamet
The Food and Drug Administration (FDA) strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana® and InvokametTM) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. Labels of the medications will be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm461876.htm Source: FDA website
Drug Warning 09-10-15
Epzicom
The Food and Drug Administration (FDA) approved Epzicom™ (abacavir sulfate/lamivudine tablets) for once-daily dosing in pediatric individuals weighing 25 kg or more. Source: FDA website
New Indications 09-21-15
Reyataz
The Food and Drug Administration (FDA) approved Reyataz® (atazanavir oral powder) for individuals aged 3 months or greater and weighing 5 kg or greater. Source: FDA website
New Indications 09-25-15
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with Yervoy® (ipilimumab injection) for the treatment of individuals with BRAF V600 wild-type unresectable or metastatic melanoma. Source: FDA website
New Indications 10-01-15
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of metastatic non-small cell lung cancer (NSCLC) in individuals whose disease has progressed after other treatments and with tumors that express PD-L1. Source: FDA website
New Indications 10-02-15
Letairis
The Food and Drug Administration (FDA) approved Letairis™ (ambrisentan tablets) in combination with tadalafil tablets for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Source: FDA website
New Indications 10-02-15
Olysio
The Food and Drug Administration (FDA) approved Olysio® (simeprevir capsules) for the treatment of hepatitis C virus (HCV)/human immunodeficiency virus (HIV)-1 co-infection, and to expand the indications and usage to include genotype 4 infection. Source: FDA website
New Indications 10-06-15
ColciGel
The Food and Drug Administration (FDA) approved ColciGel® (colchicinum 4X transdermal gel) for the treatment and prophylaxis of acute gout flares in adults. Source: FDA website
New Drug 09-21-15
Aristada
The Food and Drug Administration (FDA) approved Aristada™ (aripiprazole lauroxil extended-release injectable suspension) for the treatment of schizophrenia. The injection has once-monthly and 6-week dosing options. Source: FDA website
New Drug 10-06-15
Lonsurf
The Food and Drug Administration (FDA) approved Lonsurf® (trifluridine/tipiracil tablets) for the treatment of individuals with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. Source: FDA website
New Drug 09-22-15
Tresiba
The Food and Drug Administration (FDA) approved Tresiba® (insulin degludec injection) to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Source: FDA website
New Drug 09-25-15
Ryzodeg
The Food and Drug Administration (FDA) approved Ryzodeg® (insulin degludec/insulin aspart injection) to improve glycemic control in adults with type 1 and 2 diabetes mellitus. Source: FDA website
New Drug 09-25-15
US Compounding
US Compounding announced a voluntary recall of all lots of aseptically compounded and packaged products by USC that are not expired due to concern over lack of sterility assurance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm464086.htm. Source: FDA website
Drug Recall 09-24-15
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of advanced metastatic non-squamous non-small cell lung cancer that has progressed during or after platinum-based chemotherapy. Source: FDA website
New Indications 10-09-15
MorphaBond ER
The Food and Drug Administration (FDA) approved MorphaBond™ ER (morphine sulfate extended-release abuse-deterrent tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Source: FDA website
New Drug 10-05-15
Dyanavel XR
The Food and Drug Administration (FDA) approved Dyanavel™ XR (amphetamine extended-release oral suspension) for the treatment of attention deficit hyperactivity disorder (ADHD) in children ages 6 and older. Source: FDA website
New Drug 10-20-15
Enstilar Foam
The Food and Drug Administration (FDA) approved Enstilar® (calcipotriol/betamethasone dipropionate foam) the treatment of psoriasis vulgaris in individuals 18 years of age and older. Source: FDA website
New Drug 10-19-15
Onivyde
The Food and Drug Administration (FDA) approved Onivyde™ (irinotecan liposome injection) in combination with fluorouracil and leucovorin for the treatment of metastatic pancreatic cancer in individuals who have been previously treated with gemcitabine-based chemotherapy. Source: FDA website
New Drug 10-22-15
Vivlodex
The Food and Drug Administration (FDA) approved Vivlodex™ (meloxicam capsules) for the management of osteoarthritis pain. Source: FDA website
New Drug 10-23-15
Veltassa
The Food and Drug Administration (FDA) approved Veltassa™ (patiromer oral suspension) for the treatment of hyperkalemia. Source: FDA website
New Drug 10-21-15
Yondelis
The Food and Drug Administration (FDA) approved Yondelis® (trabectedin injection) for the treatment of two types of soft tissue sarcomas, liposarcoma and leiomyosarcoma. Source: FDA website
New Drug 10-23-15
Praxbind
The Food and Drug Administration (FDA) approved Praxbind® (idarucizumab injection) for the reversal of the blood-thinning effects of the anticoagulant Pradaxa during emergency situations. Source: FDA website
New Drug 10-16-15
Coagadex
The Food and Drug Administration (FDA) approved Coagadex® (coagulation Factor X [human]) for replacement therapy in individuals with hereditary Factor X deficiency. Source: FDA website
New Drug 10-20-15
Downing Labs
Downing Labs announced a voluntary recall of all lots of unexpired sterile products compounded and packaged by Downing Labs due to concerns over sterility assurance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm468235.htm Source: FDA website
Drug Recall 10-21-15
Acetaminophen
Medline Industries announced a voluntary recall of one lot of Acetaminophen 500 mg tablets due to mislabeling with incorrect strength. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm467076.htm Source: FDA website
Drug Recall 10-15-15
Hepatitis C treatments - Viekira Pak and Technivie
The Food and Drug Administration (FDA) is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. The FDA is requiring that product labeling be updated. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm468757.htm Source: FDA website
Drug Warning 10-22-15
Yervoy
The Food and Drug Administration (FDA) approved Yervoy® (ipilimumab injection) for use as adjuvant therapy for individuals with stage III melanoma to lower the risk that the melanoma will return following surgery. Source: FDA website
New Indication 10-28-15
Belbuca
The Food and Drug Administration (FDA) approved Belbuca™ (buprenorphine buccal film) for use in individuals with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Source: FDA website
New Drug 10-26-15
Genvoya
The Food and Drug Administration (FDA) approved Genvoya® (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 in adults and pediatric individuals 12 years of age and older. Source: FDA website
New Drug 11-05-15
Strensiq
The Food and Drug Administration (FDA) approved Strensiq™ (asfotase alfa injection) for the treatment of perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). Source: FDA website
New Drug 10-23-15
Imlygic
The Food and Drug Administration (FDA) approved Imlygic™ (talimogene laherparepvec injection) for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in individuals with melanoma that recurred after initial surgery. Source: FDA website
New Drug 10-27-15
Utibron Neohaler
The Food and Drug Administration (FDA) approved Utibron™ Neohaler® (glycopyrrolate/indacaterol oral inhalation) for the long-term maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD). Source: FDA website
New Drug 10-29-15
Seebri Neohaler
The Food and Drug Administration (FDA) approved Seebri™ Neohaler® (glycopyrrolate oral inhalation) for the long-term maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD). Source: FDA website
New Drug 10-29-15
Nucala
The Food and Drug Administration (FDA) approved Nucala® (mepolizumab injection) for add-on maintenance treatment of individuals with severe asthma aged 12 years and older and with an eosinophilic phenotype. Source: FDA website
New Drug 11-04-15
Auvi-Q
Sanofi announced a voluntary recall of all Auvi-Q (epinephrine injection) products that are currently on the market. These products have been found to have potential inaccurate dosage delivery. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm470010.htm Source: FDA website
Drug Recall 10-29-15
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (ledipasvir/sofosbuvir tablets) for expanded use in individuals with genotype 4, 5, and 6 chronic hepatitis C virus (HCV) infection and in individuals co-infected with human immunodeficiency virus (HIV). In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced genotype 1 individuals with cirrhosis. Source: FDA website
New Indications 11-12-15
Narcan
The Food and Drug Administration (FDA) approved Narcan® (naloxone nasal spray) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. Source: FDA website
New Drug 11-18-15
Adynovate
The Food and Drug Administration (FDA) approved AdynovateTM (antihemophilic factor [recombinant], PEGylated injection) for the twice-weekly treatment of hemophilia A. Source: FDA website
New Drug 11-13-15
Darzalex
The Food and Drug Administration (FDA) approved DarzalexTM (daratumumab injection) for the treatment of multiple myeloma in individuals who have received at least three prior lines of therapy. Source: FDA website
New Drug 11-16-15
Cotellic
The Food and Drug Administration (FDA) approved CotellicTM (cobimetinib tablets) for the treatment of unresectable or metastatic melanoma in individuals with a BRAF V600E or V600K mutation, in combination with Zelboraf® (vemurafenib tablets). Source: FDA website
New Drug 11-10-15
Tagrisso
The Food and Drug Administration (FDA) approved TagrissoTM (osimertinib tablets) for the treatment of individuals with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy. Source: FDA website
New Drug 11-13-15
Iodine-containing contrast agents
The Food and Drug Administration (FDA) ) is advising that rare cases of underactive thyroid have been reported in infants following use of contrast media containing iodine for medical imaging procedures. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm472995.htm Source: FDA website
Drug Warning 11-17-15
Pradaxa
The Food and Drug Administration (FDA) approved Pradaxa® (dabigatran etexilate mesylate capsules) for the prophylaxis of deep vein thrombosis (DVT) and pulmonary embolism (PE) in individuals who have undergone hip replacement surgery. Source: FDA website
New Indication 11-23-15
Caldolor
The Food and Drug Administration (FDA) approved Caldolor® (ibuprofen injection) for the management of pain and fever in pediatric individuals 6 months of age and older. Source: FDA website
New Indication 11-23-15
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of advanced renal cell carcinoma in individuals who have received prior anti-angiogenic therapy. Source: FDA website
New Indication 11-23-15
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for use as a single agent to treat individuals with BRAFV600 wild-type (WT) unresectable or metastatic melanoma. Source: FDA website
New Indication 11-23-15
Crestor
The Food and Drug Administration (FDA) approved Crestor® (rosuvastatin tablets) in pediatric individuals aged 8 to 17 years with heterozygous familial hypercholesterolemia. Source: FDA website
New Indication 12-01-15
Fluad
The Food and Drug Administration (FDA) approved Fluad® (seasonal influenza vaccine injection) to prevent seasonal flu in adults 65 years and older. This is the first FDA-approved seasonal influenza vaccine containing an adjuvant. Source: FDA website
New Drug 11-24-15
Ninlaro
The Food and Drug Administration (FDA) approved Ninlaro® (ixazomib capsules) in combination with Revlimid and dexamethasone for the treatment of multiple myeloma in individuals who have received at least one prior therapy. Source: FDA website
New Drug 11-20-15
Portrazza
The Food and Drug Administration (FDA) approved Portrazza® (necitumumab injection) in combination with gemcitabine and cisplatin to treat individuals with metastatic squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating advanced lung cancer. Source: FDA website
New Drug 11-24-15
Empliciti
The Food and Drug Administration (FDA) approved Empliciti™ (elotuzumab injection) in combination with Revlimid and dexamethasone in individuals with multiple myeloma who have previously received one to three other therapies. Source: FDA website
New Drug 11-30-15
Compounded multivitamins by Glades Drugs
The Food and Drug Administration (FDA) announced a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 which were distributed nationwide by Glades Drugs in Pahokee, Florida. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm474599.htm Source: FDA website
Drug Recall 11-25-15
OmniPod Insulin Management System by Insulet
On November 2, 2015, Insulet Corporation initiated a lot-specific voluntary Field Safety Notification for 15 lots of OmniPod. This notification was due to a slight increase in the reported cases in which the needle mechanism failed to deploy or was delayed. The affected lots have resulted in 66 Medical Device Reports, three of which required medical intervention. Contact your healthcare professional with any questions. More details including lot numbers may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm475156.htm Source: FDA website
Drug Warning 12-02-15
QuilliChew ER
The Food and Drug Administration (FDA) approved QuilliChew ER™ (methylphenidate extended-release chewable tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals aged 6 years and older. Source: FDA website
New Drug 12-07-15
Bendeka
The Food and Drug Administration (FDA) approved Bendeka™ (bendamustine low-volume injection) for the treatment of individuals with chronic lymphocytic leukemia (CLL) and for the treatment of individuals with indolent B-cell non-Hodgkin lymphoma (NHL). Source: FDA website
New Drug 12-08-15
Vonvendi
The Food and Drug Administration (FDA) approved Vonvendi (recombinant von Willebrand factor injection) for on-demand treatment and control of bleeding episodes in adults 18 years of age and older with von Willebrand disease (VWD). Source: FDA website
New Drug 12-08-15
Otiprio
The Food and Drug Administration (FDA) approved Otiprio™ (ciprofloxacin otic suspension) for the treatment of bilateral otitis media with effusion in pediatric individuals who are undergoing tympanostomy tube placement. Source: FDA website
New Drug 12-11-15
Vistogard
The Food and Drug Administration (FDA) approved Vistogard® (uridine triacetate oral granules) for post-5-fluorouracil (5-FU) or capecitabine overdose treatment. It is also indicated for individuals exhibiting early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or those who experience severe adverse reactions within 96 hours following the end of 5-FU or capecitabine administration. Source: FDA website
New Drug 12-11-15
Kanuma
The Food and Drug Administration (FDA) approved Kanuma™ (sebelipase alfa injection) for the treatment of individuals with lysosomal acid lipase deficiency. Source: FDA website
New Drug 12-08-15
Alecensa
The Food and Drug Administration (FDA) approved Alecensa® (alectinib capsules) for the treatment of individuals with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. Source: FDA website
New Drug 12-10-15
Gardasil 9
The Food and Drug Administration (FDA) approved Gardasil® 9 (human papillomavirus 9-valent recombinant vaccine injection) for males 16 through 26 years of age for the prevention of anal cancers and genital warts caused by nine human papillomavirus (HPV) types. Source: FDA website
New Indication 12-15-15
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for an expanded indication to include the first-line treatment of individuals with unresectable or metastatic melanoma. Source: FDA website
New Indication 12-18-15
Xeomin
The Food and Drug Administration (FDA) approved Xeomin® (incobotulinumtoxinA injection) for the treatment of upper limb spasticity in adults. Source: FDA website
New Indication 12-28-15
Emend
The Food and Drug Administration (FDA) approved Emend® Oral Suspension (aprepitant suspension) for the prevention of chemotherapy induced nausea and vomiting (CINV) in individuals aged 6 months and older. Source: FDA website
New Drug 12-21-15
Docetaxel
The Food and Drug Administration (FDA) approved Docetaxel Non-Alcohol formulation injection for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Source: FDA website
New Drug 12-28-15
Uptravi
The Food and Drug Administration (FDA) approved Uptravi® (selexipag tablets) for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization. Source: FDA website
New Drug 12-21-15
Zurampic
The Food and Drug Administration (FDA) approved Zurampic® (lesinurad tablets) to treat hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor. Source: FDA website
New Drug 12-22-15
Bridion
The Food and Drug Administration (FDA) approved Bridion® (sugammadex injection) for the reversal of moderate or deep neuromuscular blockade induced by rocuronium or vecuronium during surgery. Source: FDA website
New Drug 12-15-15
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) for the treatment of adults with active ankylosing spondylitis (AS). Source: FDA website
New Indication 01-19-16
Arzerra
The Food and Drug Administration (FDA) approved Arzerra® (ofatumumab injection) for extended treatment of individuals who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). Source: FDA website
New Indication 01-19-16
Kyprolis
The Food and Drug Administration (FDA) approved Kyprolis™ (carfilzomib injection) in combination with dexamethasone or lenalidomide plus dexamethasone for the treatment of individuals with relapsed or refractory multiple myeloma who have received one to three lines of therapy. Source: FDA website
New Indication 01-21-16
Emverm
The Food and Drug Administration (FDA) approved Emverm™ (mebendazole chewable tablets) for treatment of pinworm (Enterobius vermicularis), whipworm (Trichuris trichiura), common roundworm (Ascaris lumbricoides), common hookworm (Ancylostoma duodenale), and American hookworm (Necator americanus), as single or mixed infections. Source: FDA website
New Drug 01-15-16
Humulin R U-500 KwikPen
The Food and Drug Administration (FDA) approved Humulin® R U-500 KwikPen® (human insulin pre-filled injection), a highly concentrated formulation of insulin providing insulin that is 5 times more concentrated than U-100 insulin products to treat high blood sugar in type 1 and 2 diabetes. Source: FDA website
New Drug 01-21-16
Abbott's Compounding Pharmacy
Abbott's Compounding Pharmacy announced a voluntary recall of all unexpired lots of sterile compounded products due to lack of sterility assurance. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm482102.htm Source: FDA website
Drug Recall 01-16-16
Cosentyx
The Food and Drug Administration (FDA) approved Cosentyx® (secukinumab injection) for the treatment of adults with active psoriatic arthritis (PsA). Source: FDA website
New Indication 01-19-16
Botox
The Food and Drug Administration (FDA) approved Botox® (onabotulinumtoxinA injection) for the treatment of lower limb spasticity in adults to decrease the severity of increased muscle stiffness in ankle and toe muscles. Source: FDA website
New Indication 01-22-16
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) in combination with Yervoy® (ipilimumab injection) for the treatment of individuals with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. Source: FDA website
New Indication 01-25-16
Halaven
The Food and Drug Administration (FDA) approved Halaven® (eribulin mesylate injection) for the treatment of unresectable or metastatic liposarcoma in individuals who have received prior chemotherapy containing an anthracycline. Source: FDA website
New Indication 01-28-16
Emend
The Food and Drug Administration (FDA) approved Emend® (fosaprepitant dimeglumine injection) for use in combination with other antiemetic agents to prevent delayed nausea and vomiting in adults receiving initial and repeat courses of moderately emetogenic chemotherapy (MEC). Source: FDA website
New Indication 02-04-16
Dexilant SoluTab
The Food and Drug Administration (FDA) approved Dexilant™ SoluTab (dexlansoprazole delayed-release orally disintegrating tablets) for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) and the maintenance of healed erosive esophagitis (EE) and relief of heartburn in individuals 18 years and older. Source: FDA website
New Drug 01-27-16
Adzenys XR-ODT
The Food and Drug Administration (FDA) approved Adzenys XR-ODT™ (amphetamine extended-release orally disintegrating tablets) for the treatment of attention deficit hyperactivity disorder (ADHD) in individuals 6 years and older. Source: FDA website
New Drug 01-27-16
Onzetra Xsail
The Food and Drug Administration (FDA) approved Onzetra™ Xsail™ (sumatriptan nasal powder) for the treatment of migraine with or without aura in adults. Source: FDA website
New Drug 01-29-16
Zembrace SymTouch
The Food and Drug Administration (FDA) approved Zembrace™ SymTouch™ (sumatriptan succinate subcutaneous injection) for the treatment of acute migraine episodes with or without aura in adults who are inadequately managed with existing treatment regimens. Source: FDA website
New Drug 01-29-16
Zepatier
The Food and Drug Administration (FDA) approved Zepatier™ (elbasvir/grazoprevir tablets) for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections. Source: FDA website
New Drug 01-28-16
Daklinza
The Food and Drug Administration (FDA) approved Daklinza™ (daclatasvir tablets) for use in chronic hepatitis C virus (HCV) genotypes 1 and 3 with human immunodeficiency virus (HIV)-1 co-infection, advanced cirrhosis, and post-liver transplant recurrence of HCV. Source: FDA website
New Indication 02-05-16
Harvoni
The Food and Drug Administration (FDA) approved Harvoni® (ledipasvir/sofosbuvir tablets) in combination with ribavirin for 12 weeks for use in chronic hepatitis C virus (HCV) genotype 1- or 4- infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A) and for HCV genotype 1-infected individuals with decompensated cirrhosis (Child-Pugh B/C) including those who have undergone liver transplantation. Source: FDA website
New Indication 02-16-16
Ibrance
The Food and Drug Administration (FDA) approved Ibrance® (palbociclib capsules) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Source: FDA website
New Indication 02-19-16
Gazyva
The Food and Drug Administration (FDA) approved Gazyva® (obinutuzumab injection) for use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen. Source: FDA website
New Indication 02-26-16
Afinitor
The Food and Drug Administration (FDA) approved Afinitor® (everolimus tablets) for the treatment of adults with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Source: FDA website
New Indication 02-26-16
Sernivo
The Food and Drug Administration (FDA) approved Sernivo™ (betamethasone dipropionate topical spray) for the treatment of mild to moderate plaque psoriasis in individuals 18 years of age and older. Source: FDA website
New Drug 02-08-16
Xeljanz
The Food and Drug Administration (FDA) approved Xeljanz® (tofacitinib citrate extended-release tablets) for once-daily treatment of moderate to severe rheumatoid arthritis (RA) in individuals who have had an inadequate response or intolerance to methotrexate (MTX). Source: FDA website
New Drug 02-24-16
Briviact
The Food and Drug Administration (FDA) approved Briviact® (brivaracetam oral solution and tablet and injection) as add-on therapy for the treatment of partial onset seizures in individuals 16 years of age and older. Source: FDA website
New Drug 02-19-16
Complera
The Food and Drug Administration (FDA) approved labeling for Complera® (emtricitabine/tenofovir disoproxil fumarate/rilpivirine tablets) to include expanded use in pediatric individuals aged 12 to less than 18 years old for the treatment of human immunodeficiency virus (HIV)-1 infection. Source: FDA website
New Indication 03-02-16
Faslodex
The Food and Drug Administration (FDA) approved Faslodex® (fulvestrant injection) to include use in combination with palbociclib for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer whose cancer has progressed after endocrine therapy. Source: FDA website
New Indication 03-02-16
Imbruvica
The Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib capsules) as a first-line treatment for individuals with chronic lymphocytic leukemia (CLL). Source: FDA website
New Indication 03-04-16
Xalkori
The Food and Drug Administration (FDA) approved Xalkori® (crizotinib capsules) for the treatment of metastatic non-small cell lung cancer (NSCLC) in individuals whose tumors are ROSI-1 positive. Source: FDA website
New Indication 03-11-16
Cetylev
The Food and Drug Administration (FDA) approved CetylevTM (acetylcysteine effervescent tablets for oral solution) as an antidote for acetaminophen overdose to prevent or lessen liver damage after the ingestion of a potentially hepatotoxic quantity of acetaminophen. Source: FDA website
New Drug 01-29-16
Idelvion
The Food and Drug Administration (FDA) approved Idelvion® (albutrepenonacog alfa injection) for the on-demand control and prevention of bleeding episodes, management of postoperative bleeding, and as prophylaxis to reduce the frequency of bleeding episodes in hemophilia B in children and adults. Source: FDA website
New Drug 03-04-16
Odefsey
The Food and Drug Administration (FDA) approved Odefsey® (emtricitabine/rilpivirine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection. Source: FDA website
New Drug 03-01-16
Truvada
The Food and Drug Administration (FDA) approved Truvada® (emtricitabine/tenofovir disoproxil fumarate tablets) for pediatric individuals with human immunodeficiency virus (HIV)-1 weighing at least 17 kg. Source: FDA website
New Indication 03-14-16
Evomela
The Food and Drug Administration (FDA) approved Evomela™ (captisol-enabled melphalan injection) for the treatment of individuals with multiple myeloma. Specific labeling is for high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplant and palliative treatment for individuals for whom oral therapy is not appropriate. Captisol technology improves the stability of melphalan extending its use time to 5 hours, allowing for slower infusion rate, and for longer administration durations for pre-transplant chemotherapy. Source: FDA website
New Drug 03-14-16
Kovaltry
The Food and Drug Administration (FDA) approved Kovaltry® (antihemophilic factor VIII, recombinant injection) for the treatment of hemophilia A in adults and children. Source: FDA website
New Drug 03-17-16
Taltz
The Food and Drug Administration (FDA) approved Taltz® (ixekizumab injection) for the treatment of adults with moderate-to-severe plaque psoriasis. Source: FDA website
New Drug 03-22-16
Cinqair
The Food and Drug Administration (FDA) approved Cinqair® (reslizumab injection) for the maintenance treatment of severe asthma in individuals 18 years and older with an eosinophilic phenotype. Source: FDA website
New Drug 03-23-16
Eye drops
The Food and Drug Administration (FDA) is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm490862.htm Source: FDA website
Drug Warning 03-15-16
Defitelio
The Food and Drug Administration (FDA) approved Defitelio® (defibrotide injection) for the treatment of adult and pediatric individuals with hepatic veno-occlusive disease (VOD) with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation (HSCT). Source: FDA website
New Drug 03-03-16
Descovy
The Food and Drug Administration (FDA) approved Descovy® (emtricitabine/tenofovir alafenamide tablets) for the treatment of human immunodeficiency virus (HIV)-1 infection in patients 12 years of age and older, in combination with other antiretroviral agents. Source: FDA website
New Drug 04-04-16
Metformin-containing diabetes medications
The Food and Drug Administration (FDA) is requiring labeling changes regarding the recommendations for metformin-containing medications for diabetes to expand use in certain individuals with reduced kidney function. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494829.htm Source: FDA website
Drug Warning 04-08-16
Saxagliptin and alogliptin containing diabetes medications
The Food and Drug Administration (FDA) has found that type 2 diabetes medications containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in individuals who already have heart or kidney disease. The FDA is adding new warnings to the drug labels. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm494252.htm Source: FDA website
Drug Warning 04-05-16
Bromsite
The Food and Drug Administration (FDA) approved BromSite™ (bromfenac ophthalmic solution) for the treatment of inflammation and prevention of pain in individuals undergoing cataract surgery. Source: FDA website
New Drug 04-08-16
Venclexta
The Food and Drug Administration (FDA) approved Venclexta™ (venetoclax tablets) for the treatment of individuals with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. Source: FDA website
New Drug 04-11-16
Gilotrif
The Food and Drug Administration (FDA) approved Gilotrif® (afatinib tablets) for the treatment of individuals with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy. Source: FDA website
New Indication 04-15-16
G4 Platinum and G5 Mobile Continuous Glucose Monitoring receivers
Dexcom announced a voluntary recall of its Continuous Glucose Monitoring systems due to possible audible alarm failure. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm495468.htm Source: FDA website
Drug Recall 04-11-16
Focus Diagnostics Laboratory examination kits
Focus Diagnostics announced a voluntary recall of Simplexa Herpes Simplex Virus 1 and 2 Direct and Simplexa Group A Strep Direct examination kits containing the Direct Amplification Discs due to poor lamination between the sample reaction wells. This could lead to inaccurate test results. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm496099.htm Source: FDA website
Drug Recall 04-14-16
Orfadin
The Food and Drug Administration (FDA) approved Orfadin® (nitisinone oral suspension) for the treatment of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Source: FDA website
New Drug 04-26-16
Xtampza ER
The Food and Drug Administration (FDA) approved Xtampza™ ER (oxycodone extended-release capsules) for the treatment of chronic pain. Source: FDA website
New Drug 04-26-16
Bevespi Aerosphere
The Food and Drug Administration (FDA) approved Bevespi Aerosphere™ (glycopyrrolate/formoterol fumarate oral inhalation aerosol) for the long-term, maintenance treatment of airflow obstruction in individuals with chronic obstructive pulmonary disease (COPD), including bronchitis and/or emphysema. Source: FDA website
New Drug 04-25-16
Cabometyx
The Food and Drug Administration (FDA) approved Cabometyx™ (cabozantinib tablets) for the treatment of advanced renal cell carcinoma in individuals who have received prior anti-angiogenic therapy. Source: FDA website
New Drug 04-25-16
ProAir RespiClick
The Food and Drug Administration (FDA) approved ProAir RespiClick (albuterol sulfate oral inhalation powder) for the treatment or prevention of bronchospasm in children aged 4 to 11 years with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB). Source: FDA website
New Indication 04-29-16
Viekira Pak
The Food and Drug Administration (FDA) approved Viekira Pak™ (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets) without ribavirin in individuals with genotype 1b chronic hepatitis C virus (HCV) infection and compensated cirrhosis. Source: FDA website
New Indication 04-25-16
Nuplazid
The Food and Drug Administration (FDA) approved Nuplazid™ (pimavanserin tablets) for the treatment of psychosis associated with Parkinson's disease. Source: FDA website
New Drug 04-29-16
Fycompa
The Food and Drug Administration (FDA) approved Fycompa® (perampanel oral suspension) for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in individuals with epilepsy 12 years and older. Source: FDA website
New Drug 05-02-16
Akovaz
The Food and Drug Administration (FDA) approved Akovaz™ (ephedrine sulfate injection) for the management of hypotension in surgical settings. Source: FDA website
New Drug 04-29-16
Ameluz
The Food and Drug Administration (FDA) approved Ameluz® (aminolevulinic acid gel) for use in combination with photodynamic therapy for the treatment of actinic keratoses on the face and scalp. Source: FDA website
New Drug 05-10-16
Brintellix
The Food and Drug Administration (FDA) approved a brand name change for the antidepressant Brintellix® (vortioxetine tablets) to decrease the risk of prescribing and dispensing errors resulting from name confusion with the blood-thinning medication Brilinta® (ticagrelor tablets). The new brand name of the drug will be Trintellix®. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm498607.htm Source: FDA website
Drug Warning 05-02-16
Aripiprazole
The Food and Drug Administration (FDA) is warning that impulse-control problems have been reported with the use of the antipsychotic drug aripiprazole. New warnings will be added to the drug labels for all aripiprazole-containing products. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm498823.htm Source: FDA website
Drug Warning 05-03-16
Olanzapine
The Food and Drug Administration (FDA) is warning that the antipsychotic drug olanzapine can cause a rare but serious skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). New warnings will be added to the drug labels for all olanzapine-containing products. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500123.htm Source: FDA website
Drug Warning 05-10-16
Fluoroquinolones
The Food and Drug Administration (FDA) is advising that the serious side effects associated with fluoroquinolone antibacterials generally outweigh the benefits for individuals with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For individuals with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm500665.htm Source: FDA website
Drug Warning 05-12-16
Lenvima
The Food and Drug Administration (FDA) approved Lenvima® (lenvatinib capsules) in combination with everolimus for the treatment of individuals with advanced renal cell carcinoma who were previously treated with an anti-angiogenic therapy. Source: FDA website
New Indication 05-13-16
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation Adcetris® (brentuximab vedotin injection). Source: FDA website
New Indication 05-17-16
Tecentriq
The Food and Drug Administration (FDA) approved Tecentriq™ (atezolizumab injection) for the treatment of individuals with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery. Source: FDA website
New Drug 05-18-16
Nizoral
The Food and Drug Administration (FDA) is warning healthcare professionals to avoid prescribing the antifungal medication ketoconazole oral tablets for the unapproved uses of treating skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful drug interactions. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm502073.htm Source: FDA website
Drug Warning 05-19-16
Canagliflozin
The Food and Drug Administration (FDA) is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations in individuals treated with the diabetes medicine canagliflozin (Invokana®, Invokamet®). The agency will update the public when there is more information. Contact your healthcare professional with any questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm501565.htm Source: FDA website
Drug Warning 05-18-16
Invokamet
The Food and Drug Administration (FDA) approved Invokamet® (canagliflozin/metformin tablets) as a first-line treatment for adults with type 2 diabetes. Source: FDA website
New Indication 05-18-16
Fanapt
The Food and Drug Administration (FDA) approved Fanapt® (iloperidone tablets) as a maintenance treatment for adults with schizophrenia. Source: FDA website
New Indication 05-18-16
Teflaro
The Food and Drug Administration (FDA) approved Teflaro® (ceftaroline fosamil injection) in individuals aged 2 months to less than 18 years old with acute bacterial skin and skin structure infections (ABSSSI), including infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcal pneumoniae and other designated susceptible bacteria.
New Indication 05-18-16
Crestor
The Food and Drug Administration (FDA) approved Crestor® (rosuvastatin tablets) for use in pediatric patients aged 7–17 years with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C, total C, nonHDL-C, and ApoB as adjunct to diet, either alone or with other lipid-lowering treatments (e.g., LDL apheresis).
New Indication 05-18-16
Flucelvax Quadrivalent
The Food and Drug Administration (FDA) approved Flucelvax Quadrivalent® (four-strain influenza vaccine injection) for influenza virus infection prevention in individuals 4 years of age and older. Source: FDA website
New Drug 05-18-16
Probuphine
The Food and Drug Administration (FDA) approved Probuphine® (buprenorphine implant for subdermal administration) for the maintenance treatment of opioid dependence. Source: FDA website
New Drug 05-18-16
Ocaliva
The Food and Drug Administration (FDA) approved Ocaliva™ (obeticholic acid tablets) for the treatment of primary biliary cholangitis. Source: FDA website
New Drug 05-18-16
Afstyla
The Food and Drug Administration (FDA) approved Afstyla® (antihemophilic factor, recombinant, single chain injection) for the treatment of adults and children with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes. Source: FDA website
New Drug 05-18-16
Jentadueto XR
The Food and Drug Administration (FDA) approved Jentadueto® XR (linagliptin/metformin tablets) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both linagliptin and metformin are appropriate. Source: FDA website
New Drug 05-18-16
Zinbryta
The Food and Drug Administration (FDA) approved Zinbryta™ (daclizumab injection) for the treatment of relapsing forms of multiple sclerosis (MS). Source: FDA website
New Drug 05-18-16
Byvalson
The Food and Drug Administration (FDA) approved Byvalson™ (nebivolol/valsartan tablets) for the treatment of hypertension to lower blood pressure. Source: FDA website
New Drug 06-06-16
Jetrea
The Food and Drug Administration (FDA) approved Jetrea® (ocriplasmin intravitreal injection) in an "already diluted" formulation for the treatment of symptomatic vitreomacular adhesion. Source: FDA website
New Drug 06-08-16
Loperamide
The Food and Drug Administration (FDA) is warning that taking higher than recommended doses of over-the-counter (OTC) and prescription diarrhea medicine loperamide, including through abuse or misuse of the product, can cause serious heart problems that can lead to death. Contact your healthcare professional with questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505303.htm Source: FDA website
Drug Warning 06-07-16
Nature Made
Pharmavite announced a voluntary recall on specific lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination. Contact your healthcare professional with questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505761.htm Source: FDA website
Drug Warning 06-08-16
Over-the-Counter Antacid Products Containing Aspirin
The Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using over-the-counter (OTC) aspiring-containing antacids to treat heartburn, sour stomach, acid indigestion, or upset stomach. Contact your healthcare professional with questions. Details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm505190.htm Source: FDA website
Drug Warning 06-06-16
Vaxchora
The Food and Drug Administration (FDA) approved Vaxchora™ (oral cholera vaccine) for the prevention of cholera caused by serogroup 01 for use in adults aged 18 through 64 years traveling to cholera-affected regions. Source: FDA website
New Drug 06-10-16
GoNitro
The Food and Drug Administration (FDA) approved GoNitro™ (nitroglycerin powder for sublingual use) to prevent angina pectoris. Source: FDA website
New Drug 06-13-16
Lansoprazole ODT
The Food and Drug Administration (FDA) approved Lansoprazole orally disintegrating tablets for the treatment of peptic ulcer. A trade name has not yet been determined. Source: FDA website
New Drug 06-07-16
Rayaldee
The Food and Drug Administration (FDA) approved Rayaldee® (calcifediol extended-release capsules) for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels <30 ng/mL. Source: FDA website
New Drug 06-17-16
Canagliflozin and Dapagliflozin
The Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin and dapagliflozin. Contact your healthcare professional with any questions. More details may be found at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm506554.htm Source: FDA website <30 ng/mL. Source: FDA website
Drug Warning 06-14-16
Humira
The Food and Drug Administration (FDA) approved Humira® (adalimumab injection) for the treatment of non-infectious intermediate, posterior, and panuveitis. Source: FDA website
New Indication 07-01-16
Xolair
The Food and Drug Administration (FDA) approved Xolair® (omalizumab injection) for an expanded age range to include children aged 6-11 years with moderate to severe persistent asthma with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids. Source: FDA website
New Indication 07-08-16
Prevnar
The Food and Drug Administration (FDA) approved Prevnar 13® (pneumococcal 13-valent conjugate vaccine injection) for an expanded age range to include adults 18 through 49 years of age for active immunization for the prevention of pneumonia and invasive disease caused by 13 Streptococcus pneumoniae serotypes. Source: FDA website
New Indication 07-12-16
Dexilant and Dexilant SoluTab
The Food and Drug Administration (FDA) approved Dexilant® (dexlansoprazole delayed-release capsules and Dexilant® SoluTab (dexlansoprazole delayed-release orally-disintegrating tablets) for the treatment of gastroesophageal reflux disease (GERD) in individuals aged 12 to 17 years. Source: FDA website
New Indication 07-13-16
Syndros
The Food and Drug Administration (FDA) approved Syndros™ (dronabinol oral solution) for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in individuals who have failed to respond adequately to conventional antiemetic treatments. Source: FDA website
New Drug 07-05-16
Xiidra
The Food and Drug Administration (FDA) approved Xiidra™ (lifitegrast ophthalmic solution) for the treatment of the signs and symptoms of dry eye disease. Source: FDA website
New Drug 07-12-16
Epclusa
The Food and Drug Administration (FDA) approved Epclusa® (sofosbuvir/velpatasvir tablets) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Source: FDA website
New Drug 06-28-16
Prezista
The Food and Drug Administration (FDA) approved Prezista® (darunavir tablets) for expanded use in pregnant women with human immunodeficiency virus (HV) infection. Source: FDA website
New Indication 07-18-16
Berinert
The Food and Drug Administration (FDA) approved Berinert® (C1 esterase inhibitor injection) for the treatment of acute abdominal, facial, or laryngeal hereditary angioedema (HAE) attacks in individuals < 12 years old. Source: FDA website
New Indication 07-18-16
Namzaric
The Food and Drug Administration (FDA) approved Namzaric™ (memantine/donepezil extended-release capsules) for expanded use allowing individuals with moderate to severe Alzheimer’s disease who are currently stabilized on donepezil 10 mg to start directly with Namzaric. New dosage strengths were also approved: 7 mg/10 mg and 21 mg/10 mg capsules. Source: FDA website
New Indication 07-19-16
Synjardy
The Food and Drug Administration (FDA) approved Synjardy® (empagliflozin/metformin tablets) for expanded use to include treatment naïve adults with type 2 diabetes. Source: FDA website
New Indication 07-19-16
Belviq XR
The Food and Drug Administration (FDA) approved Belviq XR® (lorcaserin extended-release tablets) for use with a reduced-calorie diet and increased physical activity for chronic weight management in adults who have a body mass index (BMI) of ≥30 kg/m2 (obese) or BMI of ≥27 kg/m2 (overweight) with at least one weight-related medical condition (e.g., high blood pressure, high cholesterol, type 2 diabetes). Source: FDA website
New Drug 07-19-16
Relistor
The Food and Drug Administration (FDA) approved Relistor® (methylnaltrexone bromide tablets) for the treatment of opioid-induced constipation for individuals with pain not caused by cancer. Source: FDA website
New Drug 07-19-16
Viekira XR
The Food and Drug Administration (FDA) approved Viekira XR® (dasabuvir/ombitasvir/paritaprevir and ritonavir extended-release tablets) for the once daily treatment of adults with chronic hepatitis C virus (HCV) genotype 1 infection. Source: FDA website
New Drug 07-22-16
Adlyxin
The Food and Drug Administration (FDA) approved Adlyxin™ (lixisenatide injection) for the once-daily treatment of adults with type 2 diabetes mellitus. Source: FDA website
New Drug 07-27-16
Human chorionic gonadotropin (HCG) and sermorelin
Talon Compounding Pharmacy (TCP) announced a voluntary recall of all unexpired lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP due to a lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm512729.htm Source: FDA website
Drug Recall 07-22-16
Fluoroquinolones
The Food and Drug Administration (FDA) approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (oral or injectable) with regards to disabling and potentially permanent adverse effects affecting the tendons, muscles, joints, nerves, and central nervous system. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm513065.htm Source: FDA website
Drug Warning 07-26-16
Qbrelis
The Food and Drug Administration (FDA) approved Qbrelis™ (lisinopril oral solution) for the treatment of hypertension in adults and pediatric individuals 6 years of age and older, adjunct therapy for heart failure, and treatment of acute myocardial infarction in adults. Source: FDA website
New Drug 07-29-16
Sustol
The Food and Drug Administration (FDA) approved Sustol® (granisetron extended-release injection) for use with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. Source: FDA website
New Drug 08-10-16
Dysport
The Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA injection) for the treatment of lower limb spasticity in individuals age 2 years and older. Source: FDA website
New Indication 08-01-16
Keytruda
The Food and Drug Administration (FDA) approved Keytruda® (pembrolizumab injection) for the treatment of individuals with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Source: FDA website
New Indication 08-05-16
PharmaTech liquid drug and dietary supplement products
PharmaTech announced a voluntary recall of all their liquid products due to a potential risk of product contamination with Burkholderia cepacia. Contact your healthcare professional with any questions. More details including affected products may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm515625.htm Source: FDA website
Drug Recall 08-09-16
Arzerra
The Food and Drug Administration (FDA) approved Arzerra®(ofatumumab injection) for use in combination with fludarabine and cyclophosphamide for the treatment of individuals with relapsed chronic lymphocytic leukemia (CLL). Source: FDA website
New Indication 08-31-16
Troxyca ER
The Food and Drug Administration (FDA) approved Troxyca® ER (naltrexone/oxycodone extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. Source: FDA website
New Drug 08-19-16
Eye/wash/Eye irrigating solutions
United Exchange Corp. of Cerritos, CA announced a voluntary recall of Rugby-branded Eye Irrigating Solution and Major-branded Eye Wash due to microbial contamination. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519570.htm Source: FDA website
Drug Recall 09-07-16
GlucaGen HypoKit (glucagon rDNA origin)
Novo Nordisk announced a voluntary recall of six batches of GlucaGen HypoKit due to customer complaints of detached needles on the syringe. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519907.htm Source: FDA website
Drug Recall 09-09-16
Lamotrigine
Impax Laboratories announced a voluntary recall of one lot of Lamotrigine orally disintegrating tablets 20 mg due to incorrect labeling of blister cards. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518486.htm Source: FDA website
Drug Recall 08-29-16
Opioid pain or cough medicines combined with benzodiazepines
The Food and Drug Administration (FDA) is requiring the addition of Boxed Warnings to the drug labeling of prescription opioid pain and prescription opioid cough medicine and benzodiazepines regarding serious risks of these medications. Contact your healthcare professional with any questions. More details may be viewed at: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm518710.htm Source: FDA website
Drug Warning 08-31-16
Cuvitru
The Food and Drug Administration (FDA) approved Cuvitru® (immune globulin, human 20% subcutaneous injection) for the treatment of primary immunodeficiency disorders in individuals 2 years and older. Source: FDA website
New Drug 09-14-16
Yosprala
The Food and Drug Administration (FDA) approved Yosprala™ (omeprazole/aspirin tablets) to treat individuals who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers. Source: FDA website
New Drug 09-15-16
Kyleena
The Food and Drug Administration (FDA) approved Kyleena™ (levonorgestrel-releasing intrauterine system) for the prevention of pregnancy for up to 5 years. Source: FDA website
New Drug 09-19-16
Lomaira
The Food and Drug Administration (FDA) approved Lomaira™ (phentermine tablets) as a short-term (few weeks) adjunct in a regimen for weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity in individuals with an initial body mass index > 30 kg/m2, or > 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). Source: FDA website
New Drug 09-19-16
Invokamet XR
The Food and Drug Administration (FDA) approved Invokamet® XR (canagliflozin/metformin extended-release tablets) for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate. Source: FDA website
New Drug 09-21-16
Exondys 51
The Food and Drug Administration (FDA) approved Exondys 51™ (eteplirsen injection) for the treatment of Duchenne muscular dystrophy (DMD) in individuals with confirmed mutation of the DMD gene amenable to exon 51 skipping. Source: FDA website
New Drug 09-19-16
Wells Pharmacy Network
Wells Pharmacy Network announced a voluntary recall of all unexpired sterile products prepared between February 22, 2016 and September 14, 2016 due to concern over lack of sterility assurance. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm522103.htm Source: FDA website
Drug Recall 09-22-16
Hyoscyamine sulfate
Virtus Pharmaceuticals announced a voluntary recall of seven lots of Hyoscyamine sulfate 0.125 mg tablets, sublingual tablets, and orally disintegrating tablets due to superpotent and subpotent test results. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm520868.htm Source: FDA website
Drug Recall 09-15-16
Opdivo
The Food and Drug Administration (FDA) approved Opdivo® (nivolumab injection) for the treatment of individuals with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy. Source: FDA website
New Indication 11-10-16
Vemlidy
The Food and Drug Administration (FDA) approved Vemlidy® (tenofovir alafenamide tablets) for the treatment of adults with hepatitis B virus (HBV) infection with compensated liver disease. Source: FDA website
New Drug 11-11-16
Bonjesta
The Food and Drug Administration (FDA) approved Bonjesta (doxylamine succinate/pyridoxine HCL extended-release tablets) for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management. Source: FDA website
New Drug 11-11-16
Intrarosa
The Food and Drug Administration (FDA) approved Intrarosa™ (prasterone vaginal insert) for the treatment of women experiencing moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. Source: FDA website
New Drug 11-17-16
Essure Permanent Birth Control System
Essure labeling now includes the addition of a boxed warning regarding adverse outcomes and the potential need for removal. The labeling will also include a Patient Decision Checklist. Contact your healthcare provider with any questions. More details may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm529241.htm Source: FDA website
Drug Warning 11-15-16
Xultophy
The Food and Drug Administration (FDA) approved Xultophy® (insulin degludec/liraglutide injection) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily. Source: FDA website
New Drug 11-21-16
Soliqua
The Food and Drug Administration (FDA) approved SoliquaTM (insulin glargine/lixisenatide injection for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide. Source: FDA website
New Drug 11-21-16
Darzalex
The Food and Drug Administration (FDA) approved Darzalex® (daratumumab injection) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for relapsed or refractory multiple myeloma. Source: FDA website
New Indication 11-21-16
Jardiance
The Food and Drug Administration (FDA) approved Jardiance® (empagliflozin tablets) to reduce the risk of cardiovascular death in adults with type 2 diabetes and cardiovascular disease. Source: FDA website
New Indication 12-02-16
Belladonna Extract
Raritan Pharmaceuticals announced a voluntary recall of homeopathic products containing belladonna extract due to the potential for variation in the content of belladonna. Consult your healthcare provider with questions. More details including products affected may be viewed at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm530642.htm Source: FDA website
Drug Recall 11-25-16